N/A
Completed N=306
Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
Source: ClinicalTrials.gov NCT01216410 ↗Enrolled (actual)
306
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Intraoperative Nausea and Vomiting — 23; 31; 49 participants
Summary
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Nausea and Vomiting |
23; 31; 49 | — |
| SECONDARY Postoperative Nausea and Vomiting (PONV) |
20; 33; 39; 28; 35; 41 | — |
| SECONDARY Pruritus |
95; 93; 97 | — |
| SECONDARY Satisfaction |
94; 85; 87 | — |
| SECONDARY Maternal Hemodynamics |
16; 19; 16 | — |
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
Data sourced from ClinicalTrials.gov (NCT01216410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.