Efficacy and safety of amisulpride injection in the prevention of postoperative nausea and vomiting: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Amisulpride group:Administration of intravenous 2ml Amisulpride;placebo group:Administration of intravenous 2ml normal saline; CONDITION: Postoperative nausea and vomiting PRIMARY OUTCOME: Nausea rating scale; SECONDARY OUTCOME: blood pressure;Heart rate, pulse;breathe; INCLUSION CRITERIA: 1. 18= age =75 years old, regardless of gender; 2. Body mass inde X(BMI) between 18.0 and 30.0kg/m2 (including cut‐off value); 3. Subjects were classified as grade I‐III according to the American Society of Anesthesiologists (ASA) classification criteria; 4. Hospitalized subjects who plan to undergo abdominal surgery (including gynecological surgery) under general anesthesia (propofol/cyclopropofol anesthesia induction is allowed, propofol/cyclopropofol anesthesia maintenance is prohibited), and the expected maintenance time of inhalation anesthesia is at least 1 hour; 5. Subjects with moderate or high risk of postoperative nausea and vomiting (PONV) (score =2) were judged by the researchers according to the simplified risk score of Apfel; 6. The subjects were able to understand the procedures and methods of the clinical trial, and voluntarily participated in the trial with full informed consent signed by the subjects themselves or their legal guardia
Epistemonikos ID: a43fa1994f9680b3fd2353b8de3d2de3bc5cc611
First added on: Feb 20, 2024