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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

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机构: [1]Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu, Peoples R China [2]Sichuan Univ, West China Hosp, Res Units West China 2018RU012, Chinese Acad Med Sci, Chengdu, Peoples R China [3]Sichuan Prov Peoples Hosp, Dept Anesthesiol, Chengdu, Peoples R China [4]Affiliated Hosp Guizhou Med Univ, Dept Anesthesiol, Guiyang, Peoples R China [5]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Anesthesiol, Wuhan, Peoples R China [6]Guizhou Prov Peoples Hosp, Dept Anesthesiol, Guiyang, Peoples R China [7]Jinan Univ, Dept Anesthesiol, Affiliated Hosp 1, Guangzhou, Peoples R China [8]Xinjiang Med Univ, Dept Anesthesiol, Affiliated Hosp 1, Urumqi, Peoples R China [9]Army Med Univ, Dept Anesthesiol, Xinqiao Hosp, Chongqing, Peoples R China [10]Guangdong Acad Med Sci, Guangdong Prov People Hosp, Dept Anesthesiol, Guangzhou, Peoples R China [11]Peking Univ, Dept Anesthesiol & Crit Care Med, Hosp 1, Beijing, Peoples R China [12]Cent South Univ, Xiangya Hosp, Dept Anesthesiol, Changsha, Peoples R China [13]Nanjing Med Univ, Jiangsu Prov Hosp, Dept Anesthesiol, Affiliated Hosp 1, Nanjing, Peoples R China [14]Zhejiang Univ, Sir Run Run Shaw Hosp, Dept Anesthesiol, Sch Med, Hangzhou, Peoples R China [15]Affiliated Hosp Zunyi Med Univ, Dept Anesthesiol, Zunyi, Guizhou, Peoples R China [16]Capital Med Univ, Beijing Tongren Hosp, Dept Anesthesiol, Beijing, Peoples R China [17]Zhengzhou Univ, Dept Anesthesiol, Affiliated Hosp 1, Zhengzhou, Peoples R China [18]Capital Med Univ, Beijing Obstet & Gynecol Hosp, Dept Anesthesiol, Beijing, Peoples R China
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关键词: Ciprofol Propofol General anesthesia Injection pain Elective surgery

摘要:
OBJECTIVE: Ciprofol is a newly developed intravenous sedative-hypnotic drug. The objective of the study was to prove whether ciprofol was non-inferior to propofol for the successful induction of general anesthesia. The ideal post-induction sedation level was assessed by comparing patients' clinical symptoms and their hemodynamic effects in responding to noxious stimuli, mostly tracheal in-tubation and bispectral index (BIS) alterations following ciprofol/propofol administration. PATIENTS AND METHODS: In this multi-center, randomized, double-blind phase 3 trial, selective surgery patients were randomly assigned in a 1:1 ratio to either ciprofol 0.4 mg/kg (n = 88) or propofol 2.0 mg/kg (n = 88) groups. The primary endpoint was the percentage of patients with successful anesthesia inductions. Secondary endpoints included the times to successful induction of general anesthesia and loss of the eyelash reflex, changes in BIS, as well as safety indicators. RESULTS: The anesthesia induction success rates for both ciprofol 0.4 mg/ kg and propofol 2 mg/kg groups were 100.0%, with a 95% CI lower success limit of - 4.18% difference between the two groups, indicating that ciprofol was non-inferior to propofol. For secondary outcomes, the average time to successful anesthesia and loss of the eyelash reflex were 0.91 min and 0.80 min for ciprofol and 0.80 min and 0.71 min for propofol, respectively. The pattern of BIS changes with ciprofol was similar to propofol and stable during the anesthesia maintenance period. Safety was comparable with 88.6% TEAEs in the ciprofol group compared to 95.5% in the propofol group. The incidence of injection pain was significantly lower in the ciprofol group compared to the propofol group (6.8% vs. 20.5%, p < 0.05). In addition, the patients treated with ciprofol had a lesser increase in blood pressure and heart rate, and fewer cases with BIS > 60 within 15 min of intravenous administration, which indicated that ciprofol may provide a better ideal sedation level during the post-induction period under an equivalent dosing regimen to propofol. CONCLUSIONS: Ciprofol for patients undergoing selective surgery is a new option for the induction of general anesthesia.

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基金编号: 2018ZX09301003-001

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出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 药学
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Q2 PHARMACOLOGY & PHARMACY
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第一作者机构: [1]Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu, Peoples R China [2]Sichuan Univ, West China Hosp, Res Units West China 2018RU012, Chinese Acad Med Sci, Chengdu, Peoples R China
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通讯机构: [1]Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu, Peoples R China [2]Sichuan Univ, West China Hosp, Res Units West China 2018RU012, Chinese Acad Med Sci, Chengdu, Peoples R China
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