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

NCT07068230 | Completed Phase 4

• 2 other identifiers: EMUH-PDPH-2018-001research ethical committee
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ondansetron; Dexamethasone; Postdural Puncture Headache; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of Postdural Puncture Headache (PDPH)

  The primary outcome is the proportion of participants in each group who develop postdural puncture headache within 14 days following spinal anesthesia for elective cesarean section. Diagnosis is based on clinical criteria assessed during follow-up calls on postoperative days 7 and 14 by a blinded anesthesiologist.

  Up to 14 days postoperatively

Secondary Outcomes (4)

• Severity of PDPH

  Up to 14 days postoperatively

• Duration of PDPH

  Up to 14 days postoperatively

• Incidence of Nausea and Vomiting (N/V)

  Intraoperatively and up to 4 days postoperatively

• Neonatal Outcome (Apgar Score at 1 and 5 minutes)

  At 1 minute and 5 minutes after birth

Study Arms (3)

Ondansetron Group

EXPERIMENTAL

Participants in this group received 8 mg of intravenous ondansetron diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia.

Drug: Ondansetron 8mg

Dexamethasone Group

EXPERIMENTAL

Participants in this group received 8 mg of intravenous dexamethasone diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia.

Drug: Dexamethasone

Placebo Group

EXPERIMENTAL

Participants in this group received 5 mL of intravenous normal saline as placebo, administered 5 minutes before spinal anesthesia.

Drug: Saline

Interventions

Ondansetron 8mg DRUG

Ondansetron 8 mg IV Administered 5 minutes before spinal anesthesia

Also known as: zofran

Ondansetron Group

Dexamethasone DRUG

Dexamethasone 8 mg IV Administered 5 minutes before spinal anesthesia

Dexamethasone Group

Saline DRUG

5ml normal saline Administered 5 minutes before spinal anesthesia

Also known as: normal saline

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females of childbearing age undergoing elective cesarean section under spinal anesthesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18 to 45 years
• Body Mass Index (BMI) between 23-27 kg/m²
• American Society of Anesthesiologists (ASA) physical status I or II

You may not qualify if:

• Refusal to participate
• Conversion to general anesthesia due to failed spinal block
• Known hypersensitivity to ondansetron or dexamethasone
• Contraindications to study medications, including:
• Diabetes mellitus
• Active infection
• Prolonged QT interval
• History of tobacco or drug use
• Coagulopathy or localized infection at the spinal injection site
• High-risk pregnancy (e.g., preeclampsia, placenta previa)
• History of chronic headache or migraine

Sponsors & Collaborators

• Minia University: lead
• Faculty of Medicine, Minia University: collaborator

Study Sites (1)

El-Minia University Hospital

Minya, Minya Governorate, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache; Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Ondansetron; Dexamethasone; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• mokhtar m mohamed, MD

  El-Minia University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This was a double-blind study. Both the patients and the care providers (anesthesiologists) were blinded to the group assignments. Study medications were prepared in identical 5 mL syringes labeled A, B, or C by an independent supervisor who was not involved in patient care, drug administration, or data collection. Neither the participants nor the medical staff administering the anesthesia or assessing outcomes were aware of the group allocations
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture

Model Details: This study is a parallel assignment model in which 150 parturients undergoing elective cesarean section under spinal anesthesia were randomized into three groups in a 1:1:1 ratio to receive either intravenous ondansetron, dexamethasone, or placebo. Each participant was assigned to one intervention group and remained in that group for the duration of the study.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 16, 2025
• Study Start: October 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available beginning 6 months after publication and ending 2 years after publication
• Access Criteria: Data will be available to qualified researchers whose proposed use of the data has been approved by an independent review committee. Requests should be directed to the principal investigator via institutional contact.

Locations

EG (1)