Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

Brief Summary

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The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.

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Detailed Description

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Conditions

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Cesarean Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metoclopramide

Prophylaxis with metoclopramide and phenylephrine infusion.

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion

Phenylephrine infusion

Prophylactic phenylephrine infusion and placebo antiemetics

Group Type PLACEBO_COMPARATOR

Phenylephrine infusion

Intervention Type DRUG

Prophylactic phenylephrine infusion after spinal and placebo antiemetics

Combination Group

Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion

Group Type ACTIVE_COMPARATOR

Combination Group

Intervention Type DRUG

Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Interventions

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Metoclopramide

Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion

Intervention Type DRUG

Phenylephrine infusion

Prophylactic phenylephrine infusion after spinal and placebo antiemetics

Intervention Type DRUG

Combination Group

Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Intervention Type DRUG

Other Intervention Names

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Metoclopramide and ondansetron

Eligibility Criteria

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Inclusion Criteria

* English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
* Scheduled or unscheduled cesarean delivery under spinal anesthesia
* Height: 5 feet-5 feet 11 in.

Exclusion Criteria

* Laboring women needing an emergency cesarean delivery

* Subjects less than 18 years of age
* Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
* Allergy to ondansetron, or metoclopramide
* Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)\>160mmHg, diastolic blood pressure (DBP)\>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
* Severe Cardiac disease in pregnancy with marked functional limitations
* Diabetes type I
* Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
* Morbid obesity (body mass index (BMI)\>45)
* Inclusion in another anesthetic study involving drug administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No