PMID- 34588977
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211001
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 12
DP  - 2021
TI  - Efficacy and Safety of Fospropofol Disodium for Injection in General Anesthesia 
      Induction for Adult Patients: A Phase 3 Trial.
PG  - 687894
LID - 10.3389/fphar.2021.687894 [doi]
LID - 687894
AB  - Background: Fospropofol disodium for injection (Fospropofol(FD)) is a prodrug 
      that is metabolized into propofol to produce a general anesthesia effect when 
      administered intravenously. Objective: This study aimed to assess the efficacy 
      and safety of Fospropofol(FD) in comparison with propofol medium/long-chain fat 
      emulsion injections (propofol-MCT/LCT) for general anesthesia induction in adult 
      patients undergoing elective surgeries. Setting: Nine academic medical centers in 
      China. Method: This multicenter, randomized, double-blind, double-simulated, 
      controlled, and non-inferiority trial evaluated 540 eligible adult patients 
      randomly assigned (2:1) to the intervention (20 mg/kg Fospropofol(FD)) or control 
      (2 mg/kg propofol-MCT/LCT) groups. Main Outcome Measure: The primary efficacy 
      endpoint was the success rate, defined as a Modified Observer's Assessment of 
      Alertness/Sedation Scale score of 1 within 5 min after study drug administration. 
      The safety endpoints consisted of adverse events (AEs) related to consciousness, 
      cognitive function, hemodynamic status, liver and kidney function, and blood 
      tests. Results: A total of 347 (96.3%) and 175 (97.2%) patients in the 
      intervention and control groups, respectively, completed the study. The success 
      rate for the primary outcome was 97.7% for both study drugs. The most frequent 
      AEs in the intervention group were abnormal feeling (62.0%), blood pressure 
      reduction (13.5%), and injection site pain (13.3%). No AEs related to 
      consciousness and mental and cognitive functions or serious adverse events were 
      reported. Conclusion: Fospropofol(FD) (20 mg/kg) is not inferior to 
      propofol-MCT/LCT (2 mg/kg) in general anesthesia induction for American Society 
      of Anesthesiologists (ASA) physical status I-II adult patients undergoing 
      elective surgeries. It is safe and effective for clinical use under 
      anesthesiologist monitoring. Impact on Practice Statement: Fospropofol(FD) can 
      produce a general anesthesia effect and reduce the incidence of pain at the site 
      of injection.
CI  - Copyright (c) 2021 Wu, Zhang, Liu, Zhang and Ke.
FAU - Wu, Chao-Meng
AU  - Wu CM
AD  - Department of Anesthesiology, West China Hospital of Sichuan University and The 
      Research Units of West China, Chinese Academy of Medical Science, Chengdu, China.
FAU - Zhang, Wen-Sheng
AU  - Zhang WS
AD  - Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital of Sichuan University, Chengdu, China.
FAU - Liu, Jin
AU  - Liu J
AD  - Department of Anesthesiology, West China Hospital of Sichuan University and The 
      Research Units of West China, Chinese Academy of Medical Science, Chengdu, China.
AD  - Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital of Sichuan University, Chengdu, China.
FAU - Zhang, Wei-Yi
AU  - Zhang WY
AD  - Department of Anesthesiology, West China Hospital of Sichuan University and The 
      Research Units of West China, Chinese Academy of Medical Science, Chengdu, China.
FAU - Ke, Bo-Wen
AU  - Ke BW
AD  - Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience 
      Center, West China Hospital of Sichuan University, Chengdu, China.
LA  - eng
PT  - Journal Article
DEP - 20210913
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC8473892
OTO - NOTNLM
OT  - anesthesia induction
OT  - fospropofol
OT  - general anesthesia
OT  - injection pain
OT  - prodrug
OT  - propofol
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2021/10/01 06:00
MHDA- 2021/10/01 06:01
PMCR- 2021/09/13
CRDT- 2021/09/30 07:10
PHST- 2021/03/31 00:00 [received]
PHST- 2021/08/25 00:00 [accepted]
PHST- 2021/09/30 07:10 [entrez]
PHST- 2021/10/01 06:00 [pubmed]
PHST- 2021/10/01 06:01 [medline]
PHST- 2021/09/13 00:00 [pmc-release]
AID - 687894 [pii]
AID - 10.3389/fphar.2021.687894 [doi]
PST - epublish
SO  - Front Pharmacol. 2021 Sep 13;12:687894. doi: 10.3389/fphar.2021.687894. 
      eCollection 2021.