Effects of total intravenous anesthesia on postoperative quality of recovery and the levels of inflammatory factors in patients undergoing retroperitoneal endoscopic surgery in urology: Study protocol for a randomized, controlled trial

全静脉麻醉对泌尿外科腹膜后内镜手术患者术后恢复质量和炎症因子水平的影响:一项随机对照试验的研究方案

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Abstract

INTRODUCTION: The utilisation of propofol-based total intravenous anesthesia has been demonstrated to reduce the incidence of postoperative nausea and vomiting, as well as postoperative cognitive dysfunction, in patients undergoing general anesthesia. The objective of the present study is to explore the impact of total intravenous anaesthesia on the postoperative recovery process and the levels of inflammatory factors in urology patients undergoing retroperitoneal endoscopic surgery. METHODS: This randomized controlled clinical trial is to be carried out at the Guanyun People's Hospital, China. Eighty adult participants scheduled for urological retroperitoneoscopic surgery under general anesthesia will be randomly distributed between two groups, namely the total intravenous anesthesia group and the inhalation anesthesia group (with a total of 40 participants in each group). The random distribution of participants between the two groups will be in a 1:1 ratio. The induction of anaesthesia will be administered to all patients using a combination of propofol, cisatracurium, and sufentanil. During the maintenance of general anaesthesia, the total intravenous anesthesia group will be administered propofol and remifentanil. Conversely, the inhalation anaesthesia group will be given sevoflurane and remifentanil. The primary outcome is measured by the patient's Global Quality of Recovery-40 (QoR-40) score on post-operative day 1 (POD 1). The secondary outcomes include QoR-40 score on POD 2 and POD 3, levels of proinflammatory cytokines (tumor necrosis factor-α, interleukin-1β, and interleukin-6), pain scores at rest and while coughing, time to extubate, length of patients' stay in the post-anesthesia care unit, awakening time, ramsay sedation score on awakening, adverse events (postoperative symptoms such as nausea, vomiting, headache, respiratory depression, hypoxemia). All analyses will be conducted in the modified intention-to-treat population. DISCUSSION: This randomised controlled trial is designed to detect the effects of total intravenous anaesthesia on the quality of recovery after surgery and the levels of inflammatory factors in the postoperative period, as measured in patients undergoing retroperitoneoscopic urological surgery. The findings will yield insights that will contribute to effective postoperative recovery strategies in patients who undergo retroperitoneal laparoscopic surgery for urinary system-related procedures. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500110244).

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