Efficacy and safety of neostigmine on treating gastrointestinal dysmotility in severe acute pancreatitis patients: study protocol for a randomized controlled trial

BACKGROUND: Acute pancreatitis is a serious threat to human health and gastrointestinal dysmotility is a common complication for acute pancreatitis patients, resulting in delayed feeding, oral feeding intolerance, paralytic ileus, and abdominal compartment syndrome. Currently, there are limited treatment for this complication. Neostigmine is known to increase gastrointestinal motility and has been used to treat gastrointestinal dysmotility after surgery. However, research in treating acute pancreatitis with neostigmine is currently limited. METHODS: This trial is a randomized, placebo-controlled, double-blinded, mono-centric trial that will test the hypothesis that neostigmine can improve gastrointestinal motility in patients with severe acute pancreatitis. Up to 56 patients will be randomized in this study receiving 0.5 mg/1 ml of neostigmine methylsulfate injection twice per day or 1 ml of saline injection twice per day. Defection time (aim 1), mortality and organ failure (aim 2), borborygmus, starting of enteral nutrition and intra-abdominal pressure (aim 3), and length of ICU and hospital stay (aim 4) will be assessed. DISCUSSION: Findings from this study will provide data supporting the usage of neostigmine for treating severe acute pancreatitis patients with gastrointestinal dysmotility. TRIAL REGISTRATION: This study is registered on chictr.org.cn with the identifier as ChiCTR2200058305. Registered on April 5, 2022.