Status:
COMPLETED
Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
Lead Sponsor:
Duke University
Collaborating Sponsors:
IWK Health Centre
Conditions:
Cesarean Delivery
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT01216410
Start Date
December 1 2008
End Date
April 1 2011
Last Update
August 6 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710