{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T17:10:15Z","timestamp":1789578615558,"version":"build-2803163510"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Ciprofol (also known as cipepofol and HSK3486), is a compound similar to propofol in chemical structure and hypnotic effect. Herein we evaluated the efficacy and safety of ciprofol for sedation in outpatient gynecological procedures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This phase III multicenter randomized trial with a non-inferiority design was conducted in nine tertiary hospitals. We enrolled 135 women aged 18\u201365\u2009years who were scheduled for ambulatory gynecological procedures. Patients were randomly assigned to receive either ciprofol (0.4\u2009mg\/kg for induction and 0.2\u2009mg\/kg for maintenance) or propofol (2.0\u2009mg\/kg for induction and 1.0\u2009mg\/kg for maintenance) sedation in a 2:1 ratio. Patients and investigators for data collection and outcome assessment were blinded to study group assignments. The primary outcome was the success rate of sedation, defined as completion of procedure without remedial anesthetics. The non-inferiority margin was set at \u22128%. Secondary outcomes included time to successful induction, time to full awake, time to meet discharge criteria, and satisfaction with sedation assessed by patients and doctors. We also monitored occurrence of adverse events and injection pain.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 135 patients were enrolled; 134 patients (90 patients received ciprofol sedation and 44 patients propofol sedation) were included in final intention-to-treat analysis. The success rates were both 100% in the two groups (rate difference, 0.0%; 95% CI, \u22124.1 to 8.0%), i.e., ciprofol was non-inferior to propofol. When compared with propofol sedation, patients given ciprofol required more time to reach successful induction (median difference [MD], 2\u2009s; 95% CI, 1 to 7; <jats:italic>p<\/jats:italic> &amp;lt;\u20090.001), and required more time to reach full awake (MD, 2.3\u2009min; 95% CI, 1.4 to 3.1; <jats:italic>p<\/jats:italic> &amp;lt;\u20090.001) and discharge criteria (MD, 2.3\u2009min; 95% CI, 1.5 to 3.2; <jats:italic>p<\/jats:italic> &amp;lt;\u20090.001). Fewer patients in the ciprofol group were dissatisfied with sedation (relative risk, 0.21; 95% CI, 0.06 to 0.77; <jats:italic>p<\/jats:italic> =\u20090.024). Patients given ciprofol sedation had lower incidences of treat-emergent adverse events (34.4% [31\/90] vs. 79.5% [35\/44]; <jats:italic>p<\/jats:italic> &amp;lt;\u20090.001) and injection pain (6.7% [6\/90] vs. 61.4% [27\/44]; <jats:italic>p<\/jats:italic> &amp;lt;\u20090.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Ciprofol for sedation in ambulatory gynecological procedures was non-inferior to propofol, with less adverse events and injection pain.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial registration<\/jats:title><jats:p>ClinicalTrials.gov, identifier NCT04958746.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2024.1360508","type":"journal-article","created":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T12:19:39Z","timestamp":1713874779000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial"],"prefix":"10.3389","volume":"11","author":[{"given":"Jing","family":"Xu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengchang","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Zeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao-Hua","family":"Zou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing-Hua","family":"Ren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhongyuan","family":"Xia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hai-Hui","family":"Xie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong-Hao","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming-Jun","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong-Xin","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2024,4,23]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"3606","DOI":"10.1021\/acs.jmedchem.7b00254","article-title":"Design, synthesis, and evaluation of novel 2,6-disubstituted phenol derivatives as general anesthetics","volume":"60","author":"Qin","year":"2017","journal-title":"J Med Chem"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1111\/bcp.14363","article-title":"Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects","volume":"87","author":"Bian","year":"2021","journal-title":"Br J Clin Pharmacol"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"5484","DOI":"10.1007\/s12325-021-01914-4","article-title":"Sedation effects produced by a ciprofol initial infusion or bolus dose followed by continuous maintenance infusion in healthy subjects: a phase 1 trial","volume":"38","author":"Hu","year":"2021","journal-title":"Adv Ther"},{"key":"ref4","first-page":"13791","article-title":"Pharmacokinetic and pharmacodynamic properties of ciprofol emulsion in Chinese subjects: a single center, open-label, single-arm dose-escalation phase 1 study","volume":"13","author":"Teng","year":"2021","journal-title":"Am J Transl Res"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1007\/s11096-022-01529-x","article-title":"Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial","volume":"45","author":"Zhu","year":"2023","journal-title":"Int J Clin Pharm"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"105904","DOI":"10.1016\/j.ejps.2021.105904","article-title":"Efficacy and safety of ciprofol for the sedation\/anesthesia in patients undergoing colonoscopy: phase IIa and IIb multi-center clinical trials","volume":"164","author":"Teng","year":"2021","journal-title":"Eur J Pharm Sci"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"1043","DOI":"10.1097\/CM9.0000000000001912","article-title":"Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial","volume":"135","author":"Liu","year":"2022","journal-title":"Chin Med J"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"138","DOI":"10.1111\/bcpt.13761","article-title":"Comparison of ciprofol (HSK3486) versus propofol for the induction of deep sedation during gastroscopy and colonoscopy procedures: a multi-centre, non-inferiority, randomized, controlled phase 3 clinical trial","volume":"131","author":"Li","year":"2022","journal-title":"Basic Clin Pharmacol Toxicol"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1007\/s40263-021-00890-1","article-title":"Efficacy and safety of HSK3486 for anesthesia\/sedation in patients undergoing fiberoptic bronchoscopy: a multicenter, double-blind, propofol-controlled, randomized, phase 3 study","volume":"36","author":"Luo","year":"2022","journal-title":"CNS Drugs"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"1607","DOI":"10.26355\/eurrev_202203_28228","article-title":"Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study","volume":"26","author":"Wang","year":"2022","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"245","DOI":"10.1186\/s12871-022-01782-7","article-title":"The efficacy and safety of ciprofol use for the induction of general anesthesia in patients undergoing gynecological surgery: a prospective randomized controlled study","volume":"22","author":"Chen","year":"2022","journal-title":"BMC Anesthesiol"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1114","DOI":"10.26355\/eurrev_202202_28101","article-title":"Efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients: a multicenter, randomized, open-label, propofol-controlled phase 2 clinical trial","volume":"26","author":"Zeng","year":"2022","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"399","DOI":"10.1097\/EJA.0000000000001799","article-title":"Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: a multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial","volume":"40","author":"Liang","year":"2023","journal-title":"Eur J Anaesthesiol"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"735700","DOI":"10.3389\/fphar.2021.735700","article-title":"Safety, pharmacokinetics, and pharmacodynamics of a single bolus of the \u03b3-aminobutyric acid (GABA) receptor potentiator HSK3486 in healthy Chinese elderly and non-elderly","volume":"12","author":"Li","year":"2021","journal-title":"Front Pharmacol"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"2757","DOI":"10.1080\/07853890.2022.2129433","article-title":"Safety, pharmacokinetics and pharmacodynamics of a novel \u03b3-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment","volume":"54","author":"Hu","year":"2022","journal-title":"Ann Med"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"5063","DOI":"10.26355\/eurrev_202207_29292","article-title":"Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation","volume":"26","author":"Qin","year":"2022","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"3083","DOI":"10.1002\/sim.3697","article-title":"Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples","volume":"28","author":"Austin","year":"2009","journal-title":"Stat Med"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"110512","DOI":"10.1016\/j.jpsychores.2021.110512","article-title":"The unbearable burden of endometriosis: results from a large cohort about anxiety reduction during the first outpatient evaluation","volume":"147","author":"Arena","year":"2021","journal-title":"J Psychosom Res"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"2210747","DOI":"10.1080\/0167482X.2023.2210747","article-title":"Symptoms of anxiety and depression in women with gestational trophoblastic disease compared to women who had a miscarriage: a cross-sectional study","volume":"44","author":"Ten\u00f3rio","year":"2023","journal-title":"J Psychosom Obstet Gynaecol"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1097\/MEJ.0000000000000655","article-title":"Effect of target-controlled propofol infusion to reduce the incidence of adverse events for procedural sedation in the emergency department: a systematic review","volume":"27","author":"Burton","year":"2020","journal-title":"Eur J Emerg Med"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1007\/s00228-023-03589-y","article-title":"Effect of intravenous lidocaine on outcomes in patients receiving propofol for gastrointestinal endoscopic procedures: an updated systematic review and meta-analysis","volume":"80","author":"Wu","year":"2023","journal-title":"Eur J Clin Pharmacol"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"1733","DOI":"10.2147\/DDDT.S414166","article-title":"The effect of different doses of ciprofol in patients with painless gastrointestinal endoscopy","volume":"17","author":"Chen","year":"2023","journal-title":"Drug Des Devel Ther"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"911","DOI":"10.1097\/EJA.0000000000001715","article-title":"Discharge readiness after remimazolam versus propofol for colonoscopy: a randomised, double-blind trial","volume":"39","author":"Yao","year":"2022","journal-title":"Eur J Anaesthesiol"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"598","DOI":"10.1093\/pm\/pnx070","article-title":"Intravenous lidocaine alleviates the pain of propofol injection by local anesthetic and central analgesic effects","volume":"19","author":"Xing","year":"2018","journal-title":"Pain Med"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"842","DOI":"10.1007\/s00101-001-0234-0","article-title":"Less pain on injection by a new formulation of propofol? A comparison with propofol LCT","volume":"50","author":"Larsen","year":"2001","journal-title":"Anaesthesist"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"703","DOI":"10.1007\/s00540-017-2386-3","article-title":"Preventive effect of a vapocoolant spray on propofol-induced pain: a prospective, double-blind, randomized study","volume":"31","author":"Moon","year":"2017","journal-title":"J Anesth"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"468","DOI":"10.1046\/j.1365-2044.1998.00405.x","article-title":"Pain on injection of propofol","volume":"53","author":"Tan","year":"1998","journal-title":"Anaesthesia"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"1707","DOI":"10.2147\/DDDT.S414243","article-title":"Efficacy and safety of ciprofol for sedation\/anesthesia in patients undergoing hysteroscopy: a randomized, parallel-group, controlled trial","volume":"17","author":"Lan","year":"2023","journal-title":"Drug Des Devel Ther"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1097\/00000539-199603000-00006","article-title":"Prevention of pain on injection of propofol: a comparison of lidocaine with alfentanil","volume":"82","author":"Nathanson","year":"1996","journal-title":"Anesth Analg"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"1246","DOI":"10.1093\/pm\/pnaa316","article-title":"Median effective dose of lidocaine for the prevention of pain caused by the injection of propofol formulated with medium- and long-chain triglycerides based on lean body weight","volume":"22","author":"Tian","year":"2021","journal-title":"Pain Med"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"1699","DOI":"10.1213\/01.ANE.0000136848.54207.97","article-title":"Pain on injection: a double-blind comparison of propofol with lidocaine pretreatment versus propofol formulated with long- and medium-chain triglycerides","volume":"99","author":"Schaub","year":"2004","journal-title":"Anesth Analg"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2024.1360508\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T12:19:45Z","timestamp":1713874785000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2024.1360508\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,23]]},"references-count":31,"alternative-id":["10.3389\/fmed.2024.1360508"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2024.1360508","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,23]]},"article-number":"1360508"}}