NCT03302039

Three Protocols for Phenylephrine Administration in Cesarean Delivery

Three Protocols for Phenylephrine Administration for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cesarean Section Complications
• Spinal Anesthesia

Interventions

Type	Name	Description
DRUG	Single shot phenylephrine	A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.
DRUG	Fixed infusion phenylephrine.	Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min
DRUG	Variable infusion phenylephrine.	Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
DRUG	Bupivacaine	Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Timeline

• Start date: 2017-10-06
• Primary completion: 2018-10-01
• Completion: 2018-10-15
• First posted: 2017-10-04
• Last updated: 2018-12-17

Locations

1 site across 1 country: Egypt