A Phase 4 interventional study of Levobupivacaine and Ropivacaine in Hemodynamic Instability, Epidural and Pregnancy, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-26.
Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Phase 4, Interventional, and Treatment
INTRODUCTION:
Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being.
METHODOLOGY/DESIGN:
It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects.
DISCUSSION:
Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.
Any patient presenting in the delivery room or gynecology-obstetrics office of the hospital with prodromes, midwives or gynecologists will inform the principal investigator (PI). The IP will contact the patient to inform them of what the study consists of and if they wish to participate in it. In case of acceptance, the explanatory documentation and a questionnaire will be delivered to determine if it meets the inclusion criteria. If the pregnant patient at term meets the inclusion criteria, she is recruited to enter the study, it will also be used to resolve any doubts that the patient may have. Once the patient has signed the informed consent, the collaborating researcher (CI) of the recruiting center will be notified to contact the Althaia Innovation and Research Unit to find out the patient's assignment group. The collaborating researcher will be in charge of notifying the patient of the group to which she has been assigned (Intervention Group A or B).
Initially, the basal hemodynamic constants will be recorded: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), systemic vascular resistance (SVR), cardiac output (CO), index Pulse Pressure Variation (PPV), Stroke Volume Variation (SVV), Heart Rate (HR), Stroke Volume (SV), Partial Pressure Oxygen Saturation (SpO2) via Clearsight device ®; pain score (VAS); degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The FHR will also be recorded, as well as the different pathological patterns of the RCTG that appear, the Philips Avalon FM 30 monitor will be used for this.
The steps to follow for the administration of local anesthetic through the epidural catheter will be the following:
The mother's data (before and after AE) will be collected, including hemodynamic data: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), vascular resistance heart rate (SVR), cardiac output (CO), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (VSV), heart rate (HR), stroke volume (SV), blood saturation partial pressure of oxygen (SpO2); pain score (VAS), degree of analgesia achieved, satisfaction obtained, time onset of analgesia, level of sensory block using the pin-prick test and the hot-cold test; degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The fetal data (before and after the AE) of the FHR (values above or below the normal limits) will also be included, as well as the different pathological patterns of the RCTG that appear, due to hypotension or alterations. associated hemodynamics.
All pregnant women who will participate in this study will carry an intravenous cannula and will receive a fluid load of 500 cc. The position of the patients will be in a sitting position and the epidural puncture will be performed at the level of the L2-3 or L3-4 intervertebral space using a Tuohy 18 epidural needle. The loss of resistance technique with air or saline will be used according to the standards of our service.
A volume of 2 ml of 2% lidocaine will be administered via the epidural via the epidural catheter, after 3 minutes (it will be evaluated if undesirable effects appear: such as motor block due to accidental dural puncture, hypotension, nausea, vomiting), it will be administered to pregnant women the final volume (10 cc) of the local anesthetic randomly assigned via epidural.
After the administration of the initial bolus (Group A - Group B), the different constants or parameters to be evaluated will be recorded.
The measurement of the different hemodynamic variables will be recorded through a non-invasive device, the Clearsight®. The device will automatically determine the constants, which will be recorded at 5, 10, 15, 30, 45 and 60 minutes.
In the event of recording an episode of hypotension after the first 60 minutes, a record of all the hemodynamic variables evaluated will be made every 5 minutes for the following 60 minutes.
It will be determined which of the local anesthetics at low concentrations administered via the epidural is related to alteration of the hemodynamic parameters. To measure the different parameters, a non-invasive device (Clearsight) will be used, which will determine the existing hemodynamic alterations before, after, and during the first hour after the administration of the initial dose through the lumbar epidural catheter, as well as in the event of an episode. of hypotension or changes in FHR and/or RCTG after the first hour of catheter placement.
Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour
Drug: Levobupivacaine
Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour
Drug: Ropivacaine
To evaluate the efficacy of low-dose levobupivacaine (0.125%) (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.
To evaluate the efficacy of low-dose ropivacaine (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 10 minutes before epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 5 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 10 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 15 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 30 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 45 minutes after epidural
Systemic vascular resistance ( units of measure :dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time frame: 60 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 10 minutes before epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 5 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 10 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 15 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 30 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 45 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time frame: 60 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 10 minutes before epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 5 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 10 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 15 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 30 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 45 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time frame: 60 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 10 minutes before epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 5 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 10 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 15 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 30 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 45 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time frame: 60 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 10 minutes before epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 5 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 10 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 15 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 30 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 45 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time frame: 60 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 10 minutes before epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 5 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 10 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 15 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 30 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 45 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time frame: 60 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Area
Time frame: 10 minutes before epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Area
Time frame: 5 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Area
Time frame: 10 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Arealimits) will also be included
Time frame: 15 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Area
Time frame: 30 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Area
Time frame: 45 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface Area
Time frame: 60 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 10 minutes before epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 5 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 10 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 15 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 30 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 45 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax + PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time frame: 60 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 10 minutes before epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 5 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 10 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 15 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 30 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 45 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time frame: 60 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 10 minutes before epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 5 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 10 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 15 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 30 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 45 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time frame: 60 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 10 minutes before epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 5 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 10 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 15 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 30 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 45 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time frame: 60 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 10 minutes before epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 5 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 10 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 15 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 30 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 45 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time frame: 60 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 10 minutes before epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 5 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 10 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 15 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 30 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 45 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time frame: 60 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 10 minutes before epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 5 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 10 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 15 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 30 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 45 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time frame: 60 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 10 minutes before epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 5 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 10 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 15 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 30 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 45 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time frame: 60 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 10 minutes before epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 5 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 10 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 15 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 30 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 45 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time frame: 60 minutes after epidural
Plan to share: No
Start is estimated for Jun 2023; primary completion for Dec 2023, 6 months later.
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Studies of the drugs tested here: Levobupivacaine · Ropivacaine
Althaia Xarxa Assistencial Universitària de Manresa