PMID- 36680620
OWN - NLM
STAT- MEDLINE
DCOM- 20230501
LR  - 20230809
IS  - 2210-7711 (Electronic)
IS  - 2210-7703 (Print)
VI  - 45
IP  - 2
DP  - 2023 Apr
TI  - Efficacy and safety of ciprofol versus propofol for the induction of anesthesia 
      in adult patients: a multicenter phase 2a clinical trial.
PG  - 473-482
LID - 10.1007/s11096-022-01529-x [doi]
AB  - BACKGROUND: Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic 
      that binds to the gamma-aminobutyric acid-A receptor. AIM: To determine the 
      equally potent dose of ciprofol compared with propofol as an induction agent for 
      general anesthesia in patients undergoing selective surgery, and to assess its 
      safety. METHOD: A total of 109 patients undergoing selective non-emergency, 
      non-cardiothoracic or non-neurosurgical surgery requiring tracheal intubation for 
      general anesthesia were enrolled. Ten patients per group were assigned to 
      ciprofol-0.3, 0.4 and 0.5 mg/kg, and propofol-2.0 or 2.5 mg/kg groups, 
      respectively to receive an intravenous bolus dose. An additional 20 patients were 
      enrolled in the ciprofol-0.3, 0.5 or propofol-2.0 mg/kg groups. The primary 
      outcome was the success rate of induction defined as a Modified Observer's 
      Assessment of Alertness/Sedation (MOAA/S) </= 1 after the initial bolus dose. The 
      secondary outcomes included the time to reach MOAA/S </= 1, the time to loss of the 
      eyelash reflex, the incidences and severity of adverse events (AEs). RESULTS: The 
      success rates were 100% for all 5 groups. The mean time to MOAA/S </= 1 and the 
      time to loss of the eyelash reflex were not different among the 5 groups, 
      regardless of whether a top-up dose was needed. There were no significant 
      differences in the incidences and severity of AEs in the dose ranges investigated 
      of ciprofol vs. propofol. CONCLUSION: The efficacy and safety of a single bolus 
      dose of ciprofol-0.5 mg/kg for the general anesthesia induction in selective 
      surgery patients was comparable to that of propofol-2.0 mg/kg. TRIAL 
      REGISTRATION: Clinicaltrials.gov, NCT03698617, retrospectively registered.
CI  - (c) 2023. The Author(s).
FAU - Zhu, Qianmei
AU  - Zhu Q
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China.
FAU - Luo, Zhen
AU  - Luo Z
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China.
FAU - Wang, Xia
AU  - Wang X
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China.
FAU - Wang, Dongxin
AU  - Wang D
AD  - Department of Anesthesiology, Peking University First Hospital, Beijing, 100034, 
      China.
FAU - Li, Jun
AU  - Li J
AD  - Department of Anesthesiology, The 2nd Affiliated Hospital and Yuying Children's 
      Hospital of Wenzhou Medical University, Wenzhou, 325027, China.
FAU - Wei, Xinchuan
AU  - Wei X
AD  - Department of Anesthesiology, Sichuan Provincial People's Hospital, Chengdu, 
      610072, China.
FAU - Tang, Jun
AU  - Tang J
AD  - Department of Anesthesiology, Shanghai Fifth People's Hospital, Fudan University, 
      Shanghai, 200240, China.
FAU - Yao, Shanglong
AU  - Yao S
AD  - Department of Anesthesiology, Union Hospital, Tongji Medical College of Huazhong 
      University of Science and Technology, Wuhan, 430022, China.
FAU - Ouyang, Wen
AU  - Ouyang W
AD  - Department of Anesthesiology, The Third Xiangya Hospital, Central South 
      University, Changsha, 410013, China.
FAU - Zhang, Wensheng
AU  - Zhang W
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China.
FAU - Zuo, Yunxia
AU  - Zuo Y
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China.
FAU - Wang, Xiao
AU  - Wang X
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China. 1490829116@qq.com.
FAU - Liu, Jin
AU  - Liu J
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 
      Guoxue Lane, Wuhou District, Chengdu, 610041, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03698617
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230121
PL  - Netherlands
TA  - Int J Clin Pharm
JT  - International journal of clinical pharmacy
JID - 101554912
RN  - YI7VU623SF (Propofol)
SB  - IM
MH  - Humans
MH  - Adult
MH  - *Propofol/adverse effects
MH  - Anesthesia, General/adverse effects
PMC - PMC10147789
OTO - NOTNLM
OT  - Anesthesia
OT  - Ciprofol
OT  - Propofol
OT  - Sedation
OT  - Tracheal intubation
COIS- The authors have no relevant financial or non-financial interests to disclose.
EDAT- 2023/01/22 06:00
MHDA- 2023/05/01 06:42
PMCR- 2023/01/21
CRDT- 2023/01/21 11:14
PHST- 2022/06/09 00:00 [received]
PHST- 2022/12/06 00:00 [accepted]
PHST- 2023/05/01 06:42 [medline]
PHST- 2023/01/22 06:00 [pubmed]
PHST- 2023/01/21 11:14 [entrez]
PHST- 2023/01/21 00:00 [pmc-release]
AID - 10.1007/s11096-022-01529-x [pii]
AID - 1529 [pii]
AID - 10.1007/s11096-022-01529-x [doi]
PST - ppublish
SO  - Int J Clin Pharm. 2023 Apr;45(2):473-482. doi: 10.1007/s11096-022-01529-x. Epub 
      2023 Jan 21.