drugset / Trial / NCT07068230

Ondansetron and Dexamethasone for Prevention of PDPH, Nausea, and Vomiting

NCT07068230

Phase 4 Completed 150 enrolled Minia University
RandomizedParallel-groupDouble-blindPrevention

Summary

This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Participants were randomly assigned to one of three groups to receive either 8 mg IV ondansetron, 8 mg IV dexamethasone, or 5 mL of IV normal saline 5 minutes before spinal anesthesia. The primary objective was to evaluate the effectiveness of prophylactic ondansetron and dexamethasone in reducing the incidence of postdural puncture headache (PDPH). Secondary outcomes included severity and duration of PDPH, incidence and severity of nausea and vomiting, hemodynamic parameters, and neonatal Apgar scores. Ethical approval was obtained and verbal informed consent was collected from all participants.

Timeline

Start
2018-10-01
Primary completion
2019-09-01
Completion
2019-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg Intravenous
Subject Ondansetron Other / unclassified 8 mg Intravenous

Indications