Efficacy and safety of baclofen in the prophylaxis of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized controlled trial

Abstract

Postoperative nausea and vomiting (PONV) are among the most distressing aspects of the surgical experience, especially after laparoscopic sleeve gastrectomy (LSG). This study evaluated the efficacy and safety of baclofen for preventing PONV in patients with morbid obesity undergoing LSG. In this double-blind placebo-controlled parallel study, 100 morbidly obese patients scheduled for LSG were randomized into two groups: the control group (n = 50), which received placebo and the baclofen group (n = 50), which received 10 mg of oral baclofen one hour before the anticipated time of surgery. The severity of PONV was assessed using the Rhodes index, and the frequency of rescue analgesia and pain intensity during the first 48 h after anaesthesia were evaluated using a visual analogue scale (VAS). Serum levels of substance P, serotonin, and vasopressin at baseline and 24 h after surgery were also evaluated. As compared to the control group, baclofen treated group exhibited significant decline in the severity of PONV during the first 24 h postoperatively (P = 0.001), a significantly lower frequency of rescue analgesia doses needed during the first 24 h postoperatively (P = 0.001), a significantly lower pain intensity at 0–2 h, 6 h and 12 h postoperatively (P = 0.001) and significantly lower serum levels of substance P, serotonin, and vasopressin (P = 0.001). Moreover, baclofen was safe and tolerable, and its implication was not associated with excessive sedation or extrapyramidal side effects. Baclofen could emerge as a promising new safe cost-effective agent for preventing PONV after LSG. ClinicalTrials.gov Identifier: NCT05516953. Date of registration: 08/24/2022. URL: https://register.clinicaltrials.gov/prs/beta/studies/S000CF8D00000049/recordSummary.