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Three Protocols for Phenylephrine Administration in Cesarean Delivery

NCT ID: NCT03302039

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2018-10-15

Brief Summary

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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

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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

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Cesarean Section Complications Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Single shot

Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered.

Group Type EXPERIMENTAL

Single shot phenylephrine

Intervention Type DRUG

A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.

Bupivacaine

Intervention Type DRUG

Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Fixed infusion

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.

Group Type ACTIVE_COMPARATOR

Fixed infusion phenylephrine.

Intervention Type DRUG

Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min

Bupivacaine

Intervention Type DRUG

Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Variable infusion

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.

Group Type ACTIVE_COMPARATOR

Variable infusion phenylephrine.

Intervention Type DRUG

Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.

Bupivacaine

Intervention Type DRUG

Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Interventions

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Single shot phenylephrine

A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.

Intervention Type DRUG

Fixed infusion phenylephrine.

Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min

Intervention Type DRUG

Variable infusion phenylephrine.

Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.

Intervention Type DRUG

Bupivacaine

Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Intervention Type DRUG

Other Intervention Names

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Phenylephrine Phenylephrine Phenylephrine Marcaine

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Mukhtar, Professor

Role: STUDY_DIRECTOR

Head of research committee section in anesthesia department

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-71-2017

Identifier Type: -

Identifier Source: org_study_id