Phase 4 N=122 Randomized Quadruple-blind Prevention

Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections

Postoperative Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT01734161 ↗

Enrolled (actual)

122

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Incidence of Post-operative Nausea and/or Vomiting — 29; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Weill Medical College of Cornell University
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Post-operative Nausea and/or Vomiting	29; 24	—

Summary

Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Eligibility Criteria

Inclusion Criteria

Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have consented to study

Exclusion Criteria

allergy to dexamethasone or morphine
history of gastrointestinal disease
history of severe nausea during pregnancy (hyperemesis gravidarum)
use of anti-emetic in the past 24 hours
history of gestational diabetes or diabetes mellitus
history of hypertension prior to or during pregnancy
presence of non-viable fetus

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Data sourced from ClinicalTrials.gov (NCT01734161). 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.