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Completed

NCT Number: NCT07068230

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

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.

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nausea Nervous System Diseases Obstetric Anesthesia Problems Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

El-Minia University Hospital

Minya, Minya Governorate, Egypt

About this study

This study is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy of prophylactic intravenous administration of ondansetron and dexamethasone in reducing the incidence and severity of postdural puncture headache (PDPH), and postoperative nausea and vomiting (PONV), in parturients undergoing elective cesarean section under spinal anesthesia.

A total of 150 parturients (ASA I or II), scheduled for cesarean delivery at Minia University Hospital, were randomly allocated into three parallel groups (1:1:1 ratio) using computer-generated randomization with sealed opaque envelopes to conceal allocation.

All patients received standard spinal anesthesia with 0.5% hyperbaric bupivacaine via a 25-gauge Quincke spinal needle in the sitting position at the L3-L4 or L4-L5 interspace. Prior to spinal anesthesia, patients in:

Group A (Ondansetron group) received 8 mg ondansetron IV (diluted to 5 mL in saline),

Group B (Dexamethasone group) received 8 mg dexamethasone IV (diluted to 5 mL),

Group C (Control group) received 5 mL of 0.9% normal saline IV.

Study drugs were administered 5 minutes prior to the intrathecal injection. Blinding was maintained for patients, anesthesiologists, and outcome assessors.

PDPH was assessed for 7 days postoperatively. A standardized questionnaire and the Corbey scale were used to evaluate headache onset, severity, duration, and need for analgesics. Nausea and vomiting were assessed intraoperatively and postoperatively (up to 48 hours). Standard antiemetic rescue therapy was available as needed.

The protocol adhered to CONSORT guidelines and was approved by the Minia University Faculty of Medicine Research Ethics Committee. All participants provided written informed consent prior to enrollment.

This trial investigates whether prophylactic ondansetron or dexamethasone, individually, can significantly reduce PDPH and PONV compared to placebo. The results are expected to inform perioperative management and enhance maternal outcomes in cesarean section under spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria
  • 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

Treatment and study plan

Ondansetron 8mg

Drug

Ondansetron 8 mg IV Administered 5 minutes before spinal anesthesia

Other names: zofran

Dexamethasone

Drug

Dexamethasone 8 mg IV Administered 5 minutes before spinal anesthesia

Saline

Drug

5ml normal saline Administered 5 minutes before spinal anesthesia

Other names: normal saline

Primary outcomes

  1. Incidence of Postdural Puncture Headache (PDPH)

    Time frame: Up to 14 days postoperatively

    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.

Secondary outcomes

  1. Severity of PDPH

    Time frame: Up to 14 days postoperatively

    Severity of PDPH will be assessed using the Corbey Headache Severity Scale, which categorizes headache as:

    Mild (no limitation of daily activity),

    Moderate (some limitation of activity but no bed rest required), and

    Severe (requires bed rest). Scale: Mild to Severe - higher levels indicate worse outcome

  2. Duration of PDPH

    Time frame: Up to 14 days postoperatively

    Duration (in days) from onset to resolution of PDPH symptoms in affected participants.

  3. Incidence of Nausea and Vomiting (N/V)

    Time frame: Intraoperatively and up to 4 days postoperatively

    Incidence of intraoperative and postoperative nausea and vomiting, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = nausea and vomiting, 3 = repeated vomiting).

  4. Neonatal Outcome (Apgar Score at 1 and 5 minutes)

    Time frame: At 1 minute and 5 minutes after birth

    Neonatal wellbeing will be assessed using the Apgar Score, a standardized clinical scale that evaluates Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration.

    Scale Description:

    Minimum Score: 0 (worst outcome)

    Maximum Score: 10 (best outcome)

    Higher scores reflect better neonatal condition

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section.

Acronym: PDPH-N/V

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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