Evidence map›Paper›PMID 39068917›Full record

Trial reportDigestion2024

Randomized Controlled Trial of Remimazolam Compared with Placebo in Japanese Patients Undergoing Colonoscopy: A Phase III, Investigator-Initiated Trial.

Ryoji Ichijima, Hisatomo Ikehara, Hiroyuki Ono, Kinichi Hotta, Daisuke Yamaguchi, Mitsuru Esaki, Yosuke Minoda, Yasuhiko Nagata, Kanako Ogura, Shinsuke Kiriyama and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Digestion, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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

8 citing papers in PubMed.

  1. Trial
  2. Efficacy and Recovery of Remimazolam Versus Midazolam in Sedated Colonoscopy: A Multicenter Randomized Controlled Trial in Japan.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2026
    Trial
  3. Review
  4. Article
  5. Article
  6. Remimazolam: Promising sedative for upper gastrointestinal endoscopy.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2025
    Article
  7. Article
  8. 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

12 authors.

Ryoji IchijimaDivision of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine, Tokyo, Japan, ryoji0331@yahoo.co.jp.
Hisatomo IkeharaDivision of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine, Tokyo, Japan.
Hiroyuki OnoDivision of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
Kinichi HottaDivision of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
Daisuke YamaguchiDepartment of Gastroenterology, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Mitsuru EsakiDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yosuke MinodaDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yasuhiko NagataDepartment of Gastroenterology, Nagata Surgery and Gastroenterological Clinic, Nishitokyo-shi, Japan.
Kanako OguraDivision of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine, Tokyo, Japan.
Shinsuke KiriyamaDepartment of Gastroenterology, Kiriyama Clinic, Takasaki, Japan.
Tetsuya SumiyoshiDepartment of Gastroenterology, Tonan Hospital, Sapporo, Japan.
Yuichi KanmuraDepartment of Anesthesiology, Fujimoto General Hospital, Miyazaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopies.

methodsThis multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation with remimazolam (initial dose: 3 mg; additional dose: 1 mg) or normal saline (placebo). The primary endpoint of the study was the successful sedation rate during colonoscopy, defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤4 before the procedure, maintaining this score throughout colonoscopy, and requiring no more than five additional drug doses per 15 min.

resultsThe sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p < 0.01). The time from the end of procedure to regaining consciousness was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 (interquartile range: 0.0-10.0) min in the remimazolam group and 0.0 (interquartile range: 0.0-0.0) min in the placebo group (p = 0.02). Serious adverse events were not observed.

conclusionThe use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than placebo.

Indexed as

BenzodiazepinesColonoscopyHypnotics and SedativesAdultAgedDouble-Blind MethodEast Asian PeopleFemaleHumansJapanMaleMiddle AgedProcedural SedationTreatment OutcomeBenzodiazepinesHypnotics and SedativesremimazolamColonoscopyPlaceboRandomized control trialRemimazolamSedation

Identifiers

PMID39068917
PMCPMC11633862

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Registered trials

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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.