Prophylactic Neostigmine Infusion After Radical Cystectomy; Phase I Clinical Trial

Background: Postoperative ileus (POI) occurs in 10% to 30% of patients following abdominal surgeries, leading to prolonged hospitalization, increased complications, and elevated treatment costs. Various strategies have been proposed to prevent POI and its associated complications. Neostigmine, an acetylcholinesterase inhibitor, has demonstrated effectiveness in treating acute colonic pseudo-obstruction (Ogilvie's syndrome). However, concerns exist regarding its use following surgeries that involve intestinal manipulation, and its impact on reducing the incidence of POI after radical cystectomy and urinary diversion has not been adequately investigated. Objectives: This study aims at assessing the safety of neostigmine administration after radical cystectomy and urinary diversion, marking the first phase of a clinical trial. Methods: Twenty-four hours after radical cystectomy, 1 mg of neostigmine was administered intravenously to the selected group of patients. Drug-related complications were carefully monitored. Results: A total of 25 patients, with an average age of 63.20 ± 8.85 years, were included in the study. One patient expired 5 days post-surgery due to sepsis related to intra-abdominal abscess formation without intestinal leakage. In the remaining patients, drug-related complications were mild and self-limited. Conclusions: This study indicates that intravenous administration of 1 mg of neostigmine is relatively safe for patients undergoing radical cystectomy. Future phases of the clinical trial should focus on evaluating the efficacy of neostigmine in preventing POI following radical cystectomy.