Clinical trial NCT06512402: Epinephrine Vs Norepinephrine Infusion During Caesarean Delivery
Official title: Epinephrine Versus Norepinephrine Infusion for Prevention of Maternal Hypotension During Caesarean Delivery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypotension
Spinal Block
Cesarean Section
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of 0.03 mcg/kg/min as prophylaxis.

Being a newly introduced vasoactive agent in obstetric practice, it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes.

There are no data, till date, comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension, hypertension, and bradycardia. The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery

Detailed description: Upon arrival to the operating room, routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and 10 mg metoclopramide, and 50 mg ranitidine will be delivered. Co-load infusion of lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes; and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group Block success will be assessed after 5 minutes from injecting local anesthetic into the subarachnoid space using pinprick; and will be confirmed if sensory block level is at T4. The vasopressor will be infused in the same line with intravenous fluids using a three-way stopcock. The baseline systolic blood pressure reading will be calculated as the average of 3 readings obtained in the supine position with left-uterine displacement at two-minute intervals with a difference of \<10%.

Hemodynamic management in both groups will be as follow:

Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading or systolic blood pressure \<90 mmHg during the period from intrathecal injection to delivery of the fetus) will be managed by ephedrine 9 mg Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) will be managed by administration of ephedrine 15 mg Reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading) will be managed (if persisted \> 1-reading) by stoppage of the infusion till the next systolic blood pressure reading.

Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by stoppage of the vasopressor infusion if not associated with hypotension. The infusion will be then re-started in a reduced rate (50%) when the heart rate is more than 55 bpm. IV atropine bolus (0.5 mg) will be administered if bradycardia persisted despite stoppage of the infusion. If accompanied with hypotension, bradycardia will be managed by IV bolus of ephedrine 9 mg.

Reactive tachycardia (heart rate \>130% of baseline) not related to hypotension or ephedrine infusion, will be managed if persisted by stoppage of the infusion. The infusion will be then re-started in a reduced rate (50% of the initial dose) when heart rate will have decreased to be within 30% of the baseline reading.

Fluid administration will be continued up to a maximum of 1.5 liters. After delivery, an oxytocin bolus (0.5 IU) will be delivered over five seconds, followed by infusion at a rate of 2.5 IU/hour.

Eligibility criteria: Inclusion Criteria:

* full-term singleton pregnant women, admitted for elective cesarean delivery

Exclusion Criteria:

* Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction \< 50%, heart block, and arrhythmias),
* hypertensive disorders of pregnancy,
* peripartum bleeding,
* coagulation disorders (patients with INR \>1.4 and or platelet count \< 80000 /dL) or any contraindication to regional anesthesia,
* baseline systolic blood pressure (SBP) \< 100 mmHg

Primary outcomes:
measure: incidence of post-spinal hemodynamic instability
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
Secondary outcomes:
measure: umbilical pH
timeFrame: 5 min after delivery
measure: Apgar
timeFrame: 5 min after delivery
measure: heart rate
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
measure: systolic blood pressure
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: