A Phase 4 interventional study of Adrenaline and Ephedrine in Hypotension, sponsored by Ben marzouk Sofiene. Completed at 1 site in Tunisia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Ben marzouk Sofiene · Phase 4, Interventional, and Prevention
Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%. This can result in significant morbidity for both the mother and fetus.The purpose of this study is to determine if epinephrine is as effective and safe compared to ephedrine for maintaining arterial blood pressure during elective cesarean section under spinal anesthesia. All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
Its a prospective double-blinded controlled trial. All participants gave a written informed consent. One hundred and twenty healthy women, ASA II, with singleton pregnancies at term scheduled for elective cesarean section under spinal anesthesia are targeted for the study. They are randomized to receive either epinephrine or ephedrine. Upon arrival in the operating room, parturient was placed in the supine position with 15° left lateral tilt with routine monitoring (HR, non-invasive BP, pulse oximetry, electrocardiography). Baseline BP and HR were computed as the mean of three consecutive BP and HR readings respectively at 1-minute intervals. Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus sufentanil (5 µg) at L3-4 vertebral interspace.
Group A (for adrenaline group): received a prophylactic intravenous (i.v) bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, were given if maternal BP decreased more than 20% from the baseline value.
Group E (for ephedrine group): received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, were given if maternal BP decreased more than 20% from the baseline value. Once the spinal injection was performed a rapid intravenous (i.v.) coload with 15mL/Kg of isotonic saline solution was started through a 16 G i.v. cannula (by turning the i.v. infusion to maximum and using a pressure bag inflated to 150 mmHg). A prophylactic bolus of vasopressor was administered at the end of spinal injection. After performing anesthesia, the parturient was immediately replaced in the supine position with a 15° left lateral table tilt until delivery of the infant. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. Sensory block level was checked by cold-hot test and the Modified Bromage Scale was used for the assessment of motor block. The surgery was allowed when the sensory block level reached D4. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Epinephrine or Ephedrine bolus. Supplemental oxygen will be given only when the pulse oximeter reading decreased below 95%. After delivery, 5 IU of oxytocin diluted in 20 ml of isotonic saline solution were slowly injected over 1 minute. Then an i.v infusion was given (10 IU/500ml of isotonic saline solution at a flow rate of 28 drops/min).
Heart rate (beats/min), systolic, mean and diastolic blood pressure (mmHg) will be recorded every 1 min after spinal injection until the end of surgery. The incidence of hypotension (defined as a reduction in SBP of >20% from baseline determined just before the administration of spinal anesthesia) will be recorded. Reactive hypertension (defined as a rise of SBP >20% of baseline) will also be recorded. Bradycardia (defined as HR \<50 beats/min) will be recorded. Tachycardia (defined as a HR >140 beats/min) will also be recorded. Umbilical blood samples will be obtained by clamping it on both sides and a gas analysis will be performed to determine fetal pH, HCO3-, base excess and lactates. Furthermore, Apgar scores at 1 and 5 minutes after delivery will be recorded by the attending pediatrician, who will be unaware of the vasopressor used. The study will end when cesarean section is completed and the patient is transferred to the post-operative care unit.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's enrollment of 143 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Ben marzouk Sofiene is the lead sponsor of 3 studies on the registry; none 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.
Non-inclusion criteria:
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.
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.
All parturients received a prophylactic i.v bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.
Drug: Adrenaline
All parturients received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.E
Drug: Ephedrine
i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg
Also known as: epinehrine
i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg
delta SBP (D)
difference between baseline and the lowest systolic blood pressure.
Time frame: at the end of intrathecal injection until delivery
delta MBP (D)
difference between baseline and the lowest mean blood pressure.
Time frame: at the end of intrathecal injection until delivery
delta SBP (S)
difference between baseline and the lowest systolic blood pressure.
Time frame: at the end of intrathecal injection until the end of surgery
delta MBP (S)
difference between baseline and the lowest mean blood pressure.
Time frame: at the end of intrathecal injection until the end of surgery
time to onset of first post spinal hypotension episode
first episode of hypotension after spinal anesthesia induction
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
Incidence of post spinal hypotension
a decrease of SBP \>20% of baseline
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
Vasopressor consumption
cumulative dose of vasopressor consumption
Time frame: from the end of intrathecal injection until delivery.
Vasopressor consumption
cumulative dose of vasopressor consumption
Time frame: from the end of intrathecal injection until the end of surgery.
number of rescue boluses
number of rescue boluses before and after delivery
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of hypertension
a rise of SBP \>20% of baseline
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
tachycardia
heart rate\>140 beats/min
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of arrythmia
incidence of arrhythmic events
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of bradycardia
heart rate (HR) \< 50 beats/min
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
use of atropine
cumulative dose, if needed
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of nausea and vomiting
Measure will be done according to a simple scale: 0= no nausea and vomiting; 1= nausea or vomiting
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
foetal gas analysis: pH, Lactates, HCO3-, BE
fetal cord blood analysis will be done immediately after delivery
Time frame: At time of birth
APGAR score
range from 0 to 10,incorporates five elements: respiratory effort, heart rate, reflex irritability, muscle tone, and color A score of 0 to 3 indicates a severely depressed neonate, whereas a score of 7 to 10 is considered normal.
Time frame: at 1 and 5 minutes after birth
Ran from Sep 2018 to primary completion in Dec 2018, 3 months.
Of 60 non-industry phase 4 interventional studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's 3 months is below that.
Counting every sponsor, half of 61 studies reached it within 12 months; a quarter within 5 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Epinephrine · Ephedrine