Clinical trial NCT03302039: Three Protocols for Phenylephrine Administration in Cesarean Delivery
Official title: Three Protocols for Phenylephrine Administration for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Spinal Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 217
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: The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.

Detailed description: Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).

Eligibility criteria: Inclusion Criteria:

* Full term
* Pregnant women
* Scheduled for cesarean delivery

Exclusion Criteria:

* Pre-eclampsia
* Eclampsia
* Hemorrhage
* Cardiac dysfunction
* Baseline low heart rate (below 60 bpm)

Primary outcomes:
measure: Incidence of Post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: Incidence of severe Post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: Incidence of reactive hypertension
timeFrame: 2 hours after spinal anesthesia
measure: Systolic blood pressure
timeFrame: 2 hours after spinal anesthesia
measure: Diastolic blood pressure
timeFrame: 2 hours after spinal anesthesia
measure: Heart rate
timeFrame: 2 hours after spinal anesthesia
measure: APGAR score
timeFrame: 10 minutes after delivery
measure: umbilical arterial PH
timeFrame: 10 minutes after delivery
measure: umbilical arterial Pco2
timeFrame: 10 minutes after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References: