Midazolam Adjunct Therapy for Prevention of PONV in Gynecological Laparoscopy

Summary

This randomized controlled trial was conducted to evaluate the efficacy of adding midazolam to standard dual antiemetic prophylaxis with dexamethasone and ondansetron for the prevention of postoperative nausea and vomiting (PONV) in patients undergoing elective gynecological laparoscopic surgery.

PONV is a common postoperative complication that significantly affects patient comfort, delays recovery, and may prolong hospital stay. Despite the use of established dual prophylaxis with dexamethasone and ondansetron, a considerable proportion of patients continue to experience nausea and vomiting, particularly in high-risk populations such as females undergoing laparoscopic gynecological procedures. Midazolam, a short-acting benzodiazepine, has shown potential antiemetic properties in recent studies, but its role as an adjunct in standard prophylactic regimens remains controversial.

The study was conducted in the Department of Anesthesiology at Hameed Latif Hospital, Lahore, over a period of six months from 02-12-2025 to 01-06-2026. A total of 300 eligible patients aged 19-65 years with ASA physical status I-II undergoing elective gynecological laparoscopic surgery were enrolled after obtaining informed written consent. Patients with significant comorbidities, contraindications to study drugs, or factors influencing PONV assessment were excluded.

Participants were randomly allocated into two equal groups (150 patients each) using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes. Group A received standard prophylaxis with dexamethasone and ondansetron along with intravenous normal saline. Group B received the same dual prophylaxis in addition to intravenous midazolam at a dose of 0.05 mg/kg administered after preoxygenation and before induction of anesthesia. Blinding was maintained by using identical syringes, and drug administration was performed by an anesthesiologist not involved in outcome assessment.

All patients received standardized general anesthesia, including induction with propofol, fentanyl, and atracurium, and maintenance with isoflurane in oxygen/air mixture. Neuromuscular blockade was reversed appropriately at the end of the procedure. Postoperative care and analgesia were standardized for all patients.

The primary outcome was the efficacy of antiemetic prophylaxis, defined as a postoperative nausea and vomiting visual numeric rating scale (VNRS) score of less than 4. PONV was assessed at 0 (post-anesthesia care unit), 6, 12, and 24 hours postoperatively. Secondary outcomes included comparison of VNRS scores over time and requirement of rescue antiemetics. Rescue antiemetics were administered as per protocol when clinically indicated.

Data were analyzed using SPSS version 26.0. Continuous variables were expressed as mean ± standard deviation, and categorical variables as frequency and percentages. The Shapiro-Wilk test was used to assess normality. Group comparisons were performed using Chi-square or Fisher's exact test, with a p-value ≤0.05 considered statistically significant. Stratified analysis was also conducted for age, body mass index, ASA status, and type of surgical procedure.

Conditions

• Postoperative Nausea and Vomiting (PONV)
• Gynecological Laparoscopic Surgery
• Anesthesia Complications

Interventions

DRUG

Midazolam 0.05 mg/kg IV as adjunct to dexamethasone and ondansetron for PONV prevention

Placebo (0.9% normal saline) with dexamethasone and ondansetron for PONV prevention

Sponsors & Collaborators

• Hameed Latif Hospital, Lahore

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-02

Primary Completion

2026-06-01

Completion

2026-06-01

Countries

• Pakistan

Study Locations