PMID- 34417990
OWN - NLM
STAT- MEDLINE
DCOM- 20211011
LR  - 20220531
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 38
IP  - 10
DP  - 2021 Oct
TI  - Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical 
      Ventilation: A Clinical Trial Study Protocol.
PG  - 5412-5423
LID - 10.1007/s12325-021-01877-6 [doi]
AB  - INTRODUCTION: From previous studies of pharmacodynamic data in mice, rats, beagle 
      dogs and mini pigs, frequently in direct comparison to induction doses of 
      propofol, ciprofol produced a rapid onset of anesthesia/sedation. METHODS: A 
      phase 1 study suggested potential clinical advantages of ciprofol as a 
      sedation/anesthetic agent, with no evidence of drug-related toxicity. However, 
      the sedation effects and safety of ciprofol in intensive care unit (ICU) patients 
      with mechanical ventilation should be further confirmed in a phase 3 study with a 
      larger cohort of patients. During a phase 3, non-inferiority, multicenter, 
      single-blind, randomized, propofol controlled trial, Chinese ICU patients 
      undergoing mechanical ventilation and requiring endotracheal intubation will be 
      sedated for 6-24 h after randomization. Considering a success rate for ICU 
      sedation of 99% for ciprofol and the positive control drug propofol, a total 
      sample size of 120 subjects with mechanical ventilation will be required to 
      achieve 80% power to determine non-inferiority with a margin of 8%. Finally, 
      taking into account 10% losses, 135 patients will be enrolled and randomly 
      assigned to ciprofol (90 cases) and propofol (45 cases) groups in a 2:1 ratio. 
      The primary outcome will be the success rate of sedation satisfied by the 
      following conditions: the time within the range of Richmond Agitation and 
      Sedation Score (+ 1 ~ - 2) must account for >/= 70% of the study drug 
      administration time and without other rescue treatments. Secondary outcomes will 
      include the average time to reach the sedation goal, study drug usage, rescue 
      medication given per unit weight, extubation time, recovery time to full 
      consciousness and nursing scores. Safety endpoints will include adverse events 
      (AEs), drug related AEs and serious AEs. PLANNED OUTCOMES: The results of this 
      study will provide crucial information on the use of ciprofol for sedation of 
      patients in ICUs. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04620031.
CI  - (c) 2021. The Author(s).
FAU - Liu, Yongjun
AU  - Liu Y
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Chen, Chuanxi
AU  - Chen C
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Liu, Ning
AU  - Liu N
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Tong, Li
AU  - Tong L
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Nie, Yao
AU  - Nie Y
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Wu, Jianfeng
AU  - Wu J
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Liu, Xiao
AU  - Liu X
AD  - Department of Medical, Haisco Pharmaceutical Group Co., Ltd, Shanghai, China.
FAU - Gao, Wei
AU  - Gao W
AD  - Department of Medical, Haisco Pharmaceutical Group Co., Ltd, Shanghai, China.
FAU - Tang, Lei
AU  - Tang L
AD  - Department of Good Clinical Practice, The First Affiliated Hospital, Sun Yat-Sen 
      University, Guangzhou, China.
FAU - Guan, Xiangdong
AU  - Guan X
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China. 
      guanxd@mail.sysu.edu.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT04620031
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210821
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
MH  - *Anesthesia/adverse effects
MH  - Animals
MH  - Clinical Trials, Phase III as Topic
MH  - Dogs
MH  - Humans
MH  - Intensive Care Units
MH  - Mice
MH  - Multicenter Studies as Topic
MH  - Randomized Controlled Trials as Topic
MH  - Rats
MH  - *Respiration, Artificial
MH  - Single-Blind Method
MH  - Swine
MH  - Swine, Miniature
PMC - PMC8478731
OTO - NOTNLM
OT  - Anesthesia
OT  - Ciprofol
OT  - Mechanical ventilation
OT  - Propofol
OT  - Sedation
EDAT- 2021/08/22 06:00
MHDA- 2021/10/12 06:00
PMCR- 2021/08/21
CRDT- 2021/08/21 12:15
PHST- 2021/06/11 00:00 [received]
PHST- 2021/07/27 00:00 [accepted]
PHST- 2021/08/22 06:00 [pubmed]
PHST- 2021/10/12 06:00 [medline]
PHST- 2021/08/21 12:15 [entrez]
PHST- 2021/08/21 00:00 [pmc-release]
AID - 10.1007/s12325-021-01877-6 [pii]
AID - 1877 [pii]
AID - 10.1007/s12325-021-01877-6 [doi]
PST - ppublish
SO  - Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 
      Aug 21.