search
Back to results

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Primary Purpose

Cesarean Delivery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metoclopramide
Phenylephrine infusion
Combination Group
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Delivery focused on measuring Nausea, Vomiting

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Metoclopramide

Phenylephrine infusion

Combination Group

Arm Description

Prophylaxis with metoclopramide and phenylephrine infusion.

Prophylactic phenylephrine infusion and placebo antiemetics

Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion

Outcomes

Primary Outcome Measures

Intraoperative Nausea and Vomiting
Comparison of intraoperative nausea and vomiting between the 3 groups.

Secondary Outcome Measures

Postoperative Nausea and Vomiting (PONV)
Pruritus
Satisfaction
1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.
Maternal Hemodynamics
The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively

Full Information

First Posted
October 6, 2010
Last Updated
August 4, 2014
Sponsor
Duke University
Collaborators
IWK Health Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT01216410
Brief Title
Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
IWK Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Delivery
Keywords
Nausea, Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metoclopramide
Arm Type
Active Comparator
Arm Description
Prophylaxis with metoclopramide and phenylephrine infusion.
Arm Title
Phenylephrine infusion
Arm Type
Placebo Comparator
Arm Description
Prophylactic phenylephrine infusion and placebo antiemetics
Arm Title
Combination Group
Arm Type
Active Comparator
Arm Description
Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion
Intervention Type
Drug
Intervention Name(s)
Phenylephrine infusion
Intervention Description
Prophylactic phenylephrine infusion after spinal and placebo antiemetics
Intervention Type
Drug
Intervention Name(s)
Combination Group
Other Intervention Name(s)
Metoclopramide and ondansetron
Intervention Description
Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
Primary Outcome Measure Information:
Title
Intraoperative Nausea and Vomiting
Description
Comparison of intraoperative nausea and vomiting between the 3 groups.
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Postoperative Nausea and Vomiting (PONV)
Time Frame
0-2h, 2-6h, 6-24h
Title
Pruritus
Time Frame
0-24 hrs
Title
Satisfaction
Description
1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.
Time Frame
24 h
Title
Maternal Hemodynamics
Description
The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively
Time Frame
Intraoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23635626
Citation
Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.
Results Reference
derived

Learn more about this trial

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

We'll reach out to this number within 24 hrs