Haloperidol-Ondansetron versus Dexamethasone-Ondansetron for Prevention of Postoperative Nausea and Vomiting after Laparoscopic Gynecological Surgery: A Randomized Double-Blind Non-Inferiority Trial.

Purpose

Postoperative nausea and vomiting (PONV) is commonly seen after laparoscopic gynecological surgery despite standard prophylaxis. Dexamethasone-ondansetron is widely used but may be undesirable due to metabolic and wound-related effects. We evaluated whether haloperidol-ondansetron is non-inferior for PONV prevention.

Design

Randomized, double-blind, non-inferiority trial.

Methods

120 women (ASA I-II, aged 18 to 60 years) undergoing laparoscopic gynecological surgery were randomly assigned to receive intravenous haloperidol 1 mg plus intravenous ondansetron 4 mg (HO, n = 62) or intravenous dexamethasone 8 mg plus intravenous ondansetron 4 mg (DO, n = 58). The primary outcome was the incidence of PONV within 24 hours. Secondary outcomes included nausea severity, vomiting episodes, rescue antiemetic requirement, time to first rescue antiemetic, postoperative pain scores, sedation, delirium, and QTc interval.

Findings

PONV occurred in 45.2% (HO) and 50.0% (DO) (risk difference: -4.8%, 95% CI: -23% to 13%; risk ratio 0.90, 95% CI: 0.62 to 1.31). As the upper bound of the confidence interval (13%) was below the pre-specified non-inferiority margin of 15%, non-inferiority was established. HO was associated with lower early postoperative nausea and pain scores during the first two hours. Rescue antiemetic use, sedation, delirium, and QTc interval were comparable between groups. No patient developed QTc less than 500 milliseconds or arrhythmia.

Conclusions

Haloperidol-ondansetron is non-inferior to dexamethasone-ondansetron for PONV prophylaxis after laparoscopic gynecological surgery. Lower early postoperative pain scores were observed with haloperidol-ondansetron, although this exploratory finding should be interpreted cautiously. The regimen may be considered an alternative in patients for whom corticosteroid use is undesirable.