Dexamethasone for Prevention of Postoperative Vomiting After Laparoscopic Gynecologic Surgery (PONV-DEX-GYN)

Effect of a Preoperative Single Dose of Intravenous Dexamethasone on Postoperative Vomiting in Patients Undergoing 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: Dexamethasone; Other: Placebo (Normal Saline)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • ICT
    • Islamabad, ICT, Pakistan, 44000
      • Department of Gynecology and Obstetrics, Al-Nafees Medical College and Hospital-Isra University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior laparoscopic surgery
2. Known hypersensitivity to corticosteroids
3. Opioid use within 24 hours preoperatively
4. Ischemic heart disease
5. Uncontrolled hypertension or diabetes mellitus
6. Ongoing antiemetic therapy
7. Conversion to open surgery
8. Body mass index (BMI) > 30 kg/m²

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; Single intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision.	Drug: Dexamethasone; Single intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision.
Placebo Comparator: Placebo (Normal Saline); Single intravenous dose of normal saline (placebo) administered at induction of anesthesia.	Other: Placebo (Normal Saline); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative vomiting	Proportion of participants experiencing at least one episode of vomiting within 24 hours after surgery.	Within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for rescue antiemetics	Proportion of participants requiring rescue antiemetic medication within 24 hours postoperatively.	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Rawalpindi Medical College

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: risk factors; prophylaxis; dexamethasone; laparoscopic gynecologic surgery; postoperative nausea and vomiting (PONV)
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Pharmaceutical Preparations; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pregnadienetriols; Dexamethasone; Saline Solution
• Other Study ID Numbers: 101/RMU/2017-09-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly due to local institutional policies and consent limitations. De-identified aggregate data are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No