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

• DOI: 10.1111/bcpt.13761
• Publication Date: 2022-06-02T18:46:37Z
• Authors: Junxiang Li; Xiao Wang; Jin Liu; Xia Wang; Xiangkui Li; Yaping Wang; Wen Ouyang; Jun Li; Shanglong Yao; Zhaoqiong Zhu; Qulian Guo; Yonghao Yu; Jinhai Meng; Yunxia Zuo
• Keywords: 03 medical and health sciences; 0302 clinical medicine; Gastroscopy; Humans; Hypnotics and Sedatives; Colonoscopy; ORIGINAL ARTICLES; Deep Sedation; Propofol; 3. Good health

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 margin 8% in patients undergoing gastroscopy colonoscopy. In total, 289 were randomly allocated for surgery (259 colonoscopy 30 gastroscopy) at 1:1 ratio be given intravenous injections (0.4 mg/kg) or (1.5 mg/kg). The primary outcome success rate defined as completion no need an alternative sedative >5 top up doses within any 15-min time period. 100% group vs. 99.2% (mean difference 0.8%, 95% CI: -2.2% 4.2%). Except gastrointestinal lesions found during procedures, occurrence rates adverse drug reactions groups 31.3% 62.8%, respectively (P < 0.001). Pain on injection less common (4.9% 52.4%, P outcomes demonstrated that non-inferior regard successful procedures obvious important events occurred.