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

• Published in: Basic & clinical pharmacology & toxicology 2022-08, Vol.131 (2), p.138-148
• Main Authors: Li, Junxiang, Wang, Xiao, Liu, Jin, Wang, Xia, Li, Xiangkui, Wang, Yaping, Ouyang, Wen, Li, Jun, Yao, Shanglong, Zhu, Zhaoqiong, Guo, Qulian, Yu, Yonghao, Meng, Jinhai, Zuo, Yunxia
• Format: Article
• Language: English
• Subjects: Anesthesia; ciprofol; Colon; Colonoscopy; deep sedation; Gastroscopy; Intravenous administration; Pain; Patients; Pharmacokinetics; Propofol; Side effects
• ISSN: 1742-7835; 1742-7843
• DOI: 10.1111/bcpt.13761

Ciprofol is a propofol analogue with improved pharmacokinetic properties. A multi‐centre, non‐inferiority trial was conducted to compare the deep sedation properties of ciprofol and propofol with a non‐inferiority margin of 8% in patients undergoing gastroscopy and colonoscopy. In total, 289 patients were randomly allocated for surgery (259 colonoscopy and 30 gastroscopy) at a 1:1 ratio to be given intravenous injections of ciprofol (0.4 mg/kg) or propofol (1.5 mg/kg). The primary outcome was the success rate of colonoscopy defined as colonoscopy completion with no need for an alternative sedative or >5 ciprofol or propofol top up doses within any 15‐min time period. The success rate of colonoscopy was 100% in the ciprofol group vs. 99.2% in the propofol group (mean difference 0.8%, 95% CI: −2.2% to 4.2%). Except for the gastrointestinal lesions found during the gastroscopy and colonoscopy procedures, the occurrence rates of adverse drug reactions in the ciprofol and propofol groups were 31.3% and 62.8%, respectively (P