Dexamethasone for Prevention of Postoperative Vomiting After Laparoscopic Gynecologic Surgery

NCT07421817 | Completed

• 1 other identifier: 101/RMU/2017-09-29
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting (PONV)

Keywords

postoperative nausea and vomiting (PONV); dexamethasone; laparoscopic gynecologic surgery; prophylaxis; risk factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need for rescue antiemetics

  Within 24 hours after surgery

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Placebo (Normal Saline)

PLACEBO COMPARATOR

Single intravenous dose of normal saline (placebo) administered at induction of anesthesia.

Other: Placebo (Normal Saline)

Interventions

Dexamethasone DRUG

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

Dexamethasone

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.

Placebo (Normal Saline)

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

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

Islamabad, ICT, 44000, Pakistan

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants were randomized 1:1 to receive either intravenous dexamethasone (5 mg) or placebo at induction of anesthesia, with parallel group assignment.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: October 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)