N/A N=306 Randomized Quadruple-blind Prevention

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Cesarean Delivery

Bottom Line

View on ClinicalTrials.gov: NCT01216410 ↗

Enrolled (actual)

306

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Intraoperative Nausea and Vomiting — 23; 31; 49 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Metoclopramide (Drug); Phenylephrine infusion (Drug); Combination Group (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Duke University
Primary completion: Apr 2011

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	—

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 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

View full record on ClinicalTrials.gov →

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.