Evidence map›Paper›PMID 38281035›Full record

Trial reportTrials2024

Effect of remimazolam vs propofol in high-risk patients undergoing upper gastrointestinal endoscopy: a non-inferiority randomized controlled trial.

Zhi Li, Daming Yuan, Yu Yu, Jie Xu, Weili Yang, Li Chen, Nanbo Luo

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Zhi LiDepartment of Anesthesiology, The Second People's Hospital of Futian District Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
Daming YuanDepartment of Anesthesiology, The Second People's Hospital of Futian District Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
Yu YuDepartment of Anesthesiology, The Second People's Hospital of Futian District Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
Jie XuDepartment of Anesthesiology, The Second People's Hospital of Futian District Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
Weili YangDepartment of Gastroenterology, The Second People's Hospital of Futian District Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
Li ChenDepartment of Gastroenterology, The Second People's Hospital of Futian District Shenzhen, No. 27 Zhong Kang Road, Futian District, Shenzhen, 518000, China.
Nanbo LuoDepartment of Anesthesiology, Inst Translat Med, Shenzhen Second People's Hospital/The First Affiliated Hospital of Shenzhen University, Shenzhen, 518000, China. 316916645@qq.com.ORCID http://orcid.org/0009-0001-0702-5126
Shenzhen Second People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProcedural 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.

methodsA 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.

Indexed as

AnesthesiaPropofolBenzodiazepinesEndoscopy, GastrointestinalHumansHypnotics and SedativesBenzodiazepinesHypnotics and SedativesPropofolremimazolamHigh-risk patientsProcedural sedationRandomized controlled trialRemimazolamUpper gastrointestinal endoscopy

Identifiers

PMID38281035
PMCPMC10821577
OpenAlexW4391274970

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.