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OpenTrials
Completed

NCT Number: NCT07421817

Dexamethasone for Prevention of Postoperative Vomiting After Laparoscopic Gynecologic Surgery

Postoperative nausea and vomiting (PONV) are common and distressing complications following laparoscopic gynecologic surgery. This randomized controlled trial evaluated whether a single preoperative intravenous dose of dexamethasone reduces postoperative vomiting compared with placebo and explored patient-related risk factors associated with PONV.

Women undergoing elective laparoscopic gynecologic surgery were randomly assigned to receive dexamethasone (5 mg IV) or placebo at induction of anesthesia. The primary outcome was the incidence of postoperative vomiting within 24 hours, with secondary outcomes including nausea severity, rescue antiemetic use, and postoperative recovery parameters.

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Key information

Conditions

Postoperative Nausea and Vomiting (PONV) Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

15 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology and Obstetrics, Al-Nafees Medical College and Hospital-Isra University

Islamabad, ICT, 44000, Pakistan

About this study

This single-blind randomized controlled trial evaluated the prophylactic efficacy of a single preoperative intravenous dose of dexamethasone for preventing postoperative vomiting in women undergoing elective laparoscopic gynecologic surgery. The study was conducted at Holy Family Hospital, Rawalpindi Medical University, Pakistan, between October 1, 2017, and March 31, 2018.

Eligible women aged 15-65 years were randomized in a 1:1 ratio to receive either dexamethasone 5 mg intravenously or placebo (normal saline) at induction of anesthesia. Perioperative anesthesia and postoperative care were standardized across groups. The primary outcome was the incidence of postoperative vomiting within 24 hours after surgery. Secondary outcomes included nausea severity, need for rescue antiemetics, postoperative opioid use, and recovery parameters such as time to oral intake and mobilization. An exploratory analysis assessed patient-related predictors of postoperative nausea and vomiting, including body mass index and prior history of PONV.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 15-65 years
  • Scheduled for elective laparoscopic gynecologic surgery
  • Able to provide written informed consent (for minors, consent obtained from legal guardians)

Exclusion criteria

  • Prior laparoscopic surgery
  • Known hypersensitivity to corticosteroids
  • Opioid use within 24 hours preoperatively
  • Ischemic heart disease
  • Uncontrolled hypertension or diabetes mellitus
  • Ongoing antiemetic therapy
  • Conversion to open surgery
  • Body mass index (BMI) > 30 kg/m²

Treatment and study plan

Dexamethasone

Drug

Single intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision.

Placebo (Normal Saline)

Other

Single intravenous dose of 2 mL normal saline (placebo) administered at induction of anesthesia immediately prior to surgical incision, matched in volume to the dexamethasone administered in the experimental arm.

Primary outcomes

  1. Incidence of postoperative vomiting

    Time frame: Within 24 hours after surgery

    Proportion of participants experiencing at least one episode of vomiting within 24 hours after surgery.

Secondary outcomes

  1. Need for rescue antiemetics

    Time frame: Within 24 hours after surgery

    Proportion of participants requiring rescue antiemetic medication within 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Rawalpindi Medical College

Other

Registry information

Official study title

Effect of a Preoperative Single Dose of Intravenous Dexamethasone on Postoperative Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery

Acronym: PONV-DEX-GYN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2026
Registry last updated
Feb 20, 2026

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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