A Phase 4 interventional study of cardiac output changes with "ephedrine" and cardiac output changes with "phenylephrine" in Cardiac Output, Low, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by University Tunis El Manar · Phase 4, Interventional, and Treatment
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The purpose of the study is to evaluate the cardiac output changes after an intravenous bolus of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a cesarean delivery.
For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study includes 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of four groups.
This study will be a prospective, randomized, double-blind controlled trial. After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 4 treatment groups prior to cesarean delivery.
Group A: 9 mg of ephedrine Group B: 100 mcg of phenylephrine Group C: 8 mg of ondansetron Group D: 0,25 mcg/kg of norepinephrine Baseline arterial blood pressure and heart rate will be measured in the left lateral tilt position, before anesthesia and then every minute.The cardiac output is calculated on the apical cut 5 cavities, before anesthesia and then every 5 miutes. No fluid preloading will be administered till delivery.
The primary endpoint is cardiac output changes in each groups. The secondary endpoint is the number of provider interventions needed to maintain the SBP within 80-120% of baseline for each groups.
Bradycardia (HR less than 50 BPM) will be treated with 1 mg of Atropine. Hypotension ( decrease of more than 20% of the baseline value or a PAS \<90 mm Hg) will be treated with 6 mg of ephedrine, without any fluid loading.
The spinal anesthesia will be carried out in a seated position, level L3-L4 or L4-L5 with a slow injection over 30 seconds of a mixture of 10 mg of 0.5% Bupivacaine with 5 mcg of Sufentanil. The hot / cold test to determine the block level is required. A spinal anesthesia is validated if the cold test reaches the T4 level. The 10 ml syringe will be administered immediately after spinal anesthesia. The patient will be placed in the left lateral tilt position of 15¤, then put back into strict DD immediately after the delivery. Cardiovascular parameters (PAS, PAM, PAD, HR) will be recorded every minute until delivery. Echocardiographic measurement of cardiac output will be recorded every five minutes until delivery.
Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, cardiac output, incidence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.
99 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.
This study's enrollment of 120 is above the median of 65 across 48 interventional studies indexed under Cardiac Output, Low.
Browse Cardiac Output, Low studies →University Tunis El Manar is the lead sponsor of 75 studies on the registry; 13 are open to participants now.
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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.
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.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
will receive ephedrine :a bolus of 9 mg after SA once intervention: will receive complementary doses of ephedrine 6 mgto maintain systolic blood pressure above 80 % of baseline
Drug: cardiac output changes with "ephedrine"
will receive Phenylephrine : a bolus of 100 mcg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline
Drug: cardiac output changes with "phenylephrine"
will receive ondansetron: a bolus of 8 mg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline
Drug: cardiac output changes with "ondansetron"
will receive noradrenaline (norepinephrine) a bolus of 0,25 mcg/kg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline
Drug: cardiac output changes with "nor-epinephrine"
measure cardiac output after giving a bolus of ephedrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR . ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.
measure cardiac output after giving a bolus of phenylephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.
measure cardiac output after giving a bolus of ondansetron intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.
measure cardiac output after giving a bolus of nor-epinephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.
cardiac output changes for 120 patients
In left lateral tilt position, cardiac output is calculated on the echocardiographic apical cut 5 cavities, every 5 minutes till delivery, with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine. The cardiac output is calculated on the apical cut 5 cavities: Dc (cm3 / min) = ITV \* S \* HR Dc = cardiac output ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut. Only the closing click (B2) is visible. If B2 is not visible, the sample is placed too much in the hunting chamber, which underestimates the ITV. If B1 and B2 are visible, the sample is too close to the aortic ring, which overestimates the ITV measurement. S = surface area of the aortic ring = (aorta diameter) ₂ \* π / 4 The diameter of the aorta is the average of three measurements at the beginning of systole, on the major axis.
Time frame: at time of delivery (right after spinal anesthesia until delivery)
Maternal Blood Pressure
Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean delivery with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine
Time frame: at time of delivery (right after spinal anesthesia until delivery)
heart rate
mean heart rate during cesarean delivery with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine
Time frame: at time of delivery (right after spinal anesthesia until delivery)
Vomiting
incidence of Vomiting during cesarean section with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine
Time frame: at time of delivery (right after spinal anesthesia until delivery)
mean pH of the fetal cord blood
fetal cord blood analysis will be done immediately after delivery in order to determine the pH value in each group
Time frame: at time of delivery (right after spinal anesthesia until delivery)
Nausea
incidence of nausea during cesarean section with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine
Time frame: at time of delivery (right after spinal anesthesia until delivery)
Plan to share: No
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Ran from Feb 2017 to primary completion in Feb 2018, 12 months.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar