Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

August 4, 2014 updated by: Duke University

The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Metoclopramide
Prophylaxis with metoclopramide and phenylephrine infusion.
Drug: Metoclopramide
Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion
PLACEBO_COMPARATOR: Phenylephrine infusion
Prophylactic phenylephrine infusion and placebo antiemetics
Drug: Phenylephrine infusion
Prophylactic phenylephrine infusion after spinal and placebo antiemetics
ACTIVE_COMPARATOR: Combination Group
Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion
Drug: Combination Group
Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
Other Names:
  • Metoclopramide and ondansetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Nausea and Vomiting
Time Frame: Intraoperatively
Comparison of intraoperative nausea and vomiting between the 3 groups.
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Nausea and Vomiting (PONV)
Time Frame: 0-2h, 2-6h, 6-24h
0-2h, 2-6h, 6-24h
Pruritus
Time Frame: 0-24 hrs
0-24 hrs
Satisfaction
Time Frame: 24 h
1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.
24 h
Maternal Hemodynamics
Time Frame: Intraoperatively
The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (ESTIMATE)

October 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00012142
  • Duke-12142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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