Three Protocols for Phenylephrine Administration in Cesarean Delivery

Phase 4

Completed

• Conditions: Cesarean Section Complications; Spinal Anesthesia
• Interventions: Drug: Single shot phenylephrine; Drug: Fixed infusion phenylephrine.; Drug: Variable infusion phenylephrine.; Drug: Bupivacaine

• Registration Number: NCT03302039
• Lead Sponsor: Cairo University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-10-01
• Study First Posted: 2017-10-04
• Study Start: 2017-10-06
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-15
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

Inclusion Criteria

• Full term
• Pregnant women
• Scheduled for cesarean delivery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single shot	Single shot phenylephrine	Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered.
Fixed infusion	Fixed infusion phenylephrine.	Spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred.
Variable infusion	Variable infusion phenylephrine.	Spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure.
Single shot	Bupivacaine	Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered.
Fixed infusion	Bupivacaine	Spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred.
Variable infusion	Bupivacaine	Spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure.

Primary Outcome Measures

Name	Time	Method
Incidence of Post-spinal anesthesia hypotension	30 minutes after spinal anesthesia	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

Secondary Outcome Measures

Name	Time	Method
APGAR score	10 minutes after delivery	APGAR score of the fetus
Incidence of severe Post-spinal anesthesia hypotension	30 minutes after spinal anesthesia	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.
Incidence of reactive hypertension	2 hours after spinal anesthesia	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.
Systolic blood pressure	2 hours after spinal anesthesia	Systolic blood pressure measured in mmHg
Diastolic blood pressure	2 hours after spinal anesthesia	Diastolic blood pressure measured in mmHg
Heart rate	2 hours after spinal anesthesia	number of heart beats per minute
umbilical arterial PH	10 minutes after delivery	the PH in umbilical arterial blood
umbilical arterial Pco2	10 minutes after delivery	umbilical arterial Pco2 measured in mmHg

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt