Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
Not Applicable
Completed
- Conditions
- Cesarean Delivery
- Interventions
- Registration Number
- NCT01216410
- Lead Sponsor
- Duke University
- Brief Summary
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 306
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phenylephrine infusion Phenylephrine infusion Prophylactic phenylephrine infusion and placebo antiemetics Combination Group Combination Group Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion Metoclopramide Metoclopramide Prophylaxis with metoclopramide and phenylephrine infusion.
- Primary Outcome Measures
Name Time Method Intraoperative Nausea and Vomiting Intraoperatively Comparison of intraoperative nausea and vomiting between the 3 groups.
- Secondary Outcome Measures
Name Time Method Pruritus 0-24 hrs Postoperative Nausea and Vomiting (PONV) 0-2h, 2-6h, 6-24h Satisfaction 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.
Maternal Hemodynamics Intraoperatively The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States