Three Protocols for Phenylephrine Administration in Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302039
• Other study ID #: N-71-2017
• Status: Completed
• Phase: Phase 4
• Start date: October 6, 2017
• Est. completion date: October 15, 2018

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: October 15, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cesarean Section Complications
• Spinal Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Post-spinal anesthesia hypotension	Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus	30 minutes after spinal anesthesia
Secondary	Incidence of severe Post-spinal anesthesia hypotension	Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus.	30 minutes after spinal anesthesia
Secondary	Incidence of reactive hypertension	Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.	2 hours after spinal anesthesia
Secondary	Systolic blood pressure	Systolic blood pressure measured in mmHg	2 hours after spinal anesthesia
Secondary	Diastolic blood pressure	Diastolic blood pressure measured in mmHg	2 hours after spinal anesthesia
Secondary	Heart rate	number of heart beats per minute	2 hours after spinal anesthesia
Secondary	APGAR score	APGAR score of the fetus	10 minutes after delivery
Secondary	umbilical arterial PH	the PH in umbilical arterial blood	10 minutes after delivery
Secondary	umbilical arterial Pco2	umbilical arterial Pco2 measured in mmHg	10 minutes after delivery