Effect of modified opioid sparing anaesthesia on postoperative quality of recovery in patients undergoing laparoscopic bariatric surgery: protocol for a monocentre, double-blind randomised controlled trial - the MOSA study.

ABSTRACT

INTRODUCTION: Obesity patients undergoing laparoscopic bariatric surgery (LBS) are frequently encountered perioperative adverse events related to opioids-based anaesthesia (OBA) or opioids-free anaesthesia (OFA). While modified opioid-sparing anaesthesia (MOSA) has been shown to lower the occurrence of adverse events related to OBA and OFA. This study is to assess the efficacy of MOSA in enhancing the recovery quality among individuals undergoing LBS. METHODS AND ANALYSIS: A single-centre, prospective, double-blind, randomised controlled trial is conducted at a tertiary hospital. A total of 74 eligible participants undergoing elective LBS will be recruited and randomly allocated. Patients in the MOSA group will receive a combination of low-dose opioids, minimal dexmedetomidine, esketamine and lidocaine, while in the OBA group will receive standard general anaesthesia with opioids. Patients in both groups will receive standard perioperative care. The primary outcome is the quality of recovery-15 score assessed at 24 hours after surgery. Secondary outcomes include pain levels, anxiety and depression assessments, gastrointestinal function recovery, perioperative complication rates, opioid consumption and length of hospital stay. ETHICS AND DISSEMINATION Ethical approval has been provided by the Ethical Committee of Yan'an Hospital of Kunming City (approval No. 2023-240-01). Eligible patients will provide written informed consent to the investigator. The outcomes of this trial will be disseminated in a peer-reviewed scholarly journal. TRIAL REGISTRATION NUMBER The study protocol is registered at https//www.chictr.org.cn/ on 19 December 2023. (identifier ChiCTR2300078806). The trial was conducted using V.1.0.