Automated anesthesia systems-gastrointestinal endoscopy (AAS-GE): protocol for a multi-center, randomized controlled trial

Introduction: Maintaining an appropriate depth of anesthesia requires precise drug titration, traditionally managed manually by anesthesiologists, which can be subject to variability and delayed responses. Recent advances in artificial intelligence (AI) have enabled the development of automated anesthesia systems that show promise in improving control accuracy, reducing drug use, and managing hemodynamic stability. With the rising demand for gastrointestinal endoscopy and a shortage of anesthesiologists, AI-assisted anesthesia offers a potential solution to enhance procedural efficiency and safety. This study protocol outlines the AAS-GE trial, which aims to evaluate the effectiveness and safety of an AI-based anesthesia system compared to conventional manual control, using ciprofol as the sedative agent. Methods: This study proposes to conduct a 2-arm, parallel-group, multi-center, randomized controlled trial to evaluate the efficacy and safety of an AI-assisted anesthesia system (AAS-GE) compared to traditional manual anesthesia administration in patients undergoing painless gastrointestinal endoscopy, where approximately 420 patients will be included. In the control group, anesthesia will be initiated and managed by anesthesiologists based on patients’ vital signs and clinical judgment, without reference to the BIS value. In the AAS-GE Group, anesthesia was administered using AAS-GE, which delivers continuous boluses of anesthetic drugs tailored to the patient's height, weight, age, gender, and real-time monitored data, including anesthesia depth and vital signs. The primary outcome will be the incidence of hypoxemia during the procedure, defined as a SpO2 level below 92% at any point, with oxygen supplied at 3 L/min. Secondary outcomes will include hemodynamic parameters, anesthetic management and procedure metrics, and postoperative complications. Ethics and dissemination: This protocol has been approved by the Ethics Committee of Zhengzhou Central Hospital (Approval number: ZXYY2025055. Approved 24 April 2025. Ver. 1.1). Results will be submitted to international peer- reviewed journals. Trial registration: NCT06857344