PMID- 36599219 OWN - NLM STAT- MEDLINE DCOM- 20230131 LR - 20230403 IS - 1873-4529 (Electronic) IS - 0952-8180 (Linking) VI - 85 DP - 2023 May TI - Efficacy and safety of Ciprofol for procedural sedation and anesthesia in non-operating room settings. PG - 111047 LID - S0952-8180(22)00405-6 [pii] LID - 10.1016/j.jclinane.2022.111047 [doi] AB - STUDY OBJECTIVE: Ciprofol, a novel intravenous anesthetic, provides rapid recovery in patients undergoing colonoscopy. We aimed to examine the efficacy and safety of ciprofol in comparison with propofol for sedation or anesthesia in non-operating room settings including endoscopic submucosal dissection, endoscopic retrograde cholangiopancreatography, and flexible bronchoscopy (FB). DESIGN: Prospective, randomized, double-blind, parallel-group clinical trial. SETTING: University-affiliated teaching hospital. PATIENTS: We recruited 207 patients scheduled for an endoscopic procedure from October 2021 to December 2021. INTERVENTIONS: Patients were randomized into three groups according to the dose during induction (n = 69 each): 1) ciprofol 6 mg/kg/h, 2) ciprofol 8 mg/kg/h, or 3) propofol 40 mg/kg/h. Ciprofol or propofol was administered throughout the procedure. MEASUREMENTS: The primary outcome was the success rate of sedation or anesthesia for the procedures. Secondary outcomes included induction time, endoscope insertion time, recovery time, discharge time, incidence of drug-related adverse events (AEs), neurological and inflammatory outcomes. MAIN RESULTS: The procedure success rates in the three groups were 100%. The induction time in the 6 (3.3 +/- 1.0 min) and 8 mg/kg/h (2.9 +/- 0.6 min) ciprofol groups was longer than that in the propofol group (2.5 +/- 0.6 min) only in patients undergoing FB (p = 0.004). The time for patients to be fully alert and discharged from the post-anesthesia care unit was comparable across the three groups (p > 0.05). The incidence of drug-related AEs in the propofol and 6 and 8 mg/kg/h ciprofol groups was 84.1%, 76.8%, and 79.7%. No pain on injection was reported by ciprofol groups. Neurological outcomes and inflammatory responses were comparable among the three groups. CONCLUSIONS: Ciprofol induced a level of sedation or anesthesia equivalent to that induced by propofol in non-operating room settings except for a prolonged induction time in patients undergoing FB. Ciprofol had a safety profile similar to that of propofol. No pain on injection was reported by ciprofol. CI - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Zhong, Jing AU - Zhong J AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China; Fudan Zhangjiang Institute, Shanghai, China; Department of Anesthesiology, Zhongshan Wusong Hospital, Fudan University, Shanghai, China. FAU - Zhang, Jinlin AU - Zhang J AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. FAU - Fan, Yu AU - Fan Y AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. FAU - Zhu, Min AU - Zhu M AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. FAU - Zhao, Xining AU - Zhao X AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. FAU - Zuo, Zhiyi AU - Zuo Z AD - Department of Anesthesiology, University of Virginia, Charlottesville, VA, USA. Electronic address: zz3c@virginia.edu. FAU - Zhou, Xiushi AU - Zhou X AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. Electronic address: zhou.xiushi@zs-hospital.sh.cn. FAU - Miao, Changhong AU - Miao C AD - Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China. Electronic address: miao.changhong@zs-hospital.sh.cn. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230102 PL - United States TA - J Clin Anesth JT - Journal of clinical anesthesia JID - 8812166 RN - YI7VU623SF (Propofol) RN - 0 (Anesthetics, Intravenous) RN - 0 (Hypnotics and Sedatives) SB - IM MH - Humans MH - *Propofol/adverse effects MH - Prospective Studies MH - Anesthetics, Intravenous/adverse effects MH - *Anesthesia MH - Colonoscopy MH - Hypnotics and Sedatives/adverse effects MH - Conscious Sedation/adverse effects/methods OTO - NOTNLM OT - Ciprofol OT - Endoscopic procedures OT - Flexible bronchoscopy OT - Procedural sedation and anesthesia OT - Propofol COIS- Declaration of Competing Interest The work described has not been submitted elsewhere for publication, in whole or in part, and all the authors listed have approved the enclosed manuscript. There are no potential competing interests. EDAT- 2023/01/05 06:00 MHDA- 2023/02/01 06:00 CRDT- 2023/01/04 18:07 PHST- 2022/09/18 00:00 [received] PHST- 2022/12/11 00:00 [revised] PHST- 2022/12/25 00:00 [accepted] PHST- 2023/01/05 06:00 [pubmed] PHST- 2023/02/01 06:00 [medline] PHST- 2023/01/04 18:07 [entrez] AID - S0952-8180(22)00405-6 [pii] AID - 10.1016/j.jclinane.2022.111047 [doi] PST - ppublish SO - J Clin Anesth. 2023 May;85:111047. doi: 10.1016/j.jclinane.2022.111047. Epub 2023 Jan 2.