PMID- 38281035
OWN - NLM
STAT- MEDLINE
DCOM- 20240129
LR  - 20240130
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 25
IP  - 1
DP  - 2024 Jan 27
TI  - Effect of remimazolam vs propofol in high-risk patients undergoing upper 
      gastrointestinal endoscopy: a non-inferiority randomized controlled trial.
PG  - 92
LID - 10.1186/s13063-024-07934-z [doi]
LID - 92
AB  - BACKGROUND: Procedural sedation is essential for optimizing upper 
      gastrointestinal endoscopy, particularly in high-risk patients with multiple 
      underlying diseases. Respiratory and circulatory complications present 
      significant challenges for procedural sedation in this population. This 
      non-inferiority randomized controlled trial aims to investigate the safety and 
      comfort of remimazolam compared to propofol for procedural sedation during upper 
      gastrointestinal endoscopy in high-risk patients. METHODS: A total of 576 
      high-risk patients scheduled to undergo upper gastrointestinal endoscopy are 
      planned to be enrolled in this study and randomly allocated to either the 
      remimazolam or propofol group. The primary outcome measure is a composite 
      endpoint, which includes (1) achieving a Modified Observer's Alertness/Sedation 
      scale (MOAA/S) score </= 3 before endoscope insertion, (2) successful completion of 
      the endoscopic procedure, (3) the absence of significant respiratory instability 
      during the endoscopy and treatment, and (4) the absence of significant 
      circulatory instability during the examination. The noninferiority margin was 
      10%. Any adverse events (AEs) that occur will be reported. DISCUSSION: This trial 
      aims to determine whether remimazolam is non-inferior to propofol for procedural 
      sedation during upper gastrointestinal endoscopy in high-risk patients, regarding 
      success rate, complication incidence, patient comfort, and satisfaction. TRIAL 
      REGISTRATION 2A AND 2B: Chinese Clinical Trial Registry ClinicalTrials.gov 
      ChiCTR2200066527. Registered on 7 December 2022.
CI  - (c) 2024. The Author(s).
FAU - Li, Zhi
AU  - Li Z
AD  - Department of Anesthesiology, The Second People's Hospital of Futian District 
      Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
FAU - Yuan, Daming
AU  - Yuan D
AD  - Department of Anesthesiology, The Second People's Hospital of Futian District 
      Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
FAU - Yu, Yu
AU  - Yu Y
AD  - Department of Anesthesiology, The Second People's Hospital of Futian District 
      Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
FAU - Xu, Jie
AU  - Xu J
AD  - Department of Anesthesiology, The Second People's Hospital of Futian District 
      Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
FAU - Yang, Weili
AU  - Yang W
AD  - Department of Gastroenterology, The Second People's Hospital of Futian District 
      Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
FAU - Chen, Li
AU  - Chen L
AD  - Department of Gastroenterology, The Second People's Hospital of Futian District 
      Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
FAU - Luo, Nanbo
AU  - Luo N
AUID- ORCID: 0009-0001-0702-5126
AD  - Department of Anesthesiology, Inst Translat Med, Shenzhen Second People's 
      Hospital/The First Affiliated Hospital of Shenzhen University, Shenzhen, 518000, 
      China. 316916645@qq.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20240127
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - YI7VU623SF (Propofol)
RN  - 7V4A8U16MB (remimazolam)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 0 (Hypnotics and Sedatives)
SB  - IM
MH  - Humans
MH  - *Propofol/adverse effects
MH  - Benzodiazepines
MH  - Endoscopy, Gastrointestinal/adverse effects/methods
MH  - *Anesthesia
MH  - Hypnotics and Sedatives/adverse effects
PMC - PMC10821577
OTO - NOTNLM
OT  - High-risk patients
OT  - Procedural sedation
OT  - Randomized controlled trial
OT  - Remimazolam
OT  - Upper gastrointestinal endoscopy
COIS- The authors declare that they have no competing interests. Name and contact 
      information for the trial sponsor 5b Primary sponsor: Shenzhen Futian District 
      Health Commission (+86 0755-82918108)
EDAT- 2024/01/28 07:44
MHDA- 2024/01/29 06:44
PMCR- 2024/01/27
CRDT- 2024/01/27 23:25
PHST- 2023/08/06 00:00 [received]
PHST- 2024/01/16 00:00 [accepted]
PHST- 2024/01/29 06:44 [medline]
PHST- 2024/01/28 07:44 [pubmed]
PHST- 2024/01/27 23:25 [entrez]
PHST- 2024/01/27 00:00 [pmc-release]
AID - 10.1186/s13063-024-07934-z [pii]
AID - 7934 [pii]
AID - 10.1186/s13063-024-07934-z [doi]
PST - epublish
SO  - Trials. 2024 Jan 27;25(1):92. doi: 10.1186/s13063-024-07934-z.