Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

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

PHASE2

Total Enrollment

980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-05-31

Brief Summary

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Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

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Detailed Description

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Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Conditions

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Anesthesia, Obstetrical Anesthesia, Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A

This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

5 ml normal saline will be given before spinal anesthesia

Group B

This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section

Interventions

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Phenylephrine

it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section

Intervention Type DRUG

Placebo

5 ml normal saline will be given before spinal anesthesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion Criteria

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No