Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Completed · Not applicable · Has a placebo group

Conditions studied: Cesarean Delivery

In brief

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

Key facts

Study ID

NCT01216410

Run by

Duke University

People needed

306

Starts

2008-12-01

Expected to finish

2011-04-01

Last updated by the study team

2014-08-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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