MedTrace Logo

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

NCT07068230 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-07-18

No results posted yet for this study

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.

Conditions

  • Postdural Puncture Headache
  • Postoperative Nausea and Vomiting
  • Obstetric Anesthesia Problems

Interventions

DRUG

Ondansetron 8mg

Ondansetron 8 mg IV Administered 5 minutes before spinal anesthesia

DRUG

Dexamethasone

Dexamethasone 8 mg IV Administered 5 minutes before spinal anesthesia

DRUG

Saline

5ml normal saline Administered 5 minutes before spinal anesthesia

Sponsors & Collaborators

  • Faculty of Medicine, Minia University

    collaborator UNKNOWN

  • Minia University

    lead OTHER

Principal Investigators

  • mokhtar m mohamed, MD · El-Minia University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068230 on ClinicalTrials.gov