ArticleTrials2022
Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04727034 (A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy), which is not on this map. Cited by 7 papers.
What it found
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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.
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.
A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Who cites it
7 citing papers in PubMed, 13 citations in OpenAlex.
- Comparative effects of remimazolam and propofol on hemodynamic stability during sedation for painless gastroscopy: a randomized clinical trial.BMC anesthesiology · 2025Trial
- Sedation in endoscopy: Current practices and future innovations.World journal of gastrointestinal endoscopy · 2025Article
- Remimazolam's clinical application and safety: A signal detection analysis based on FAERS data and literature support.PloS one · 2025Article
- [Remimazolam-Update on basic pharmacologic principles and clinical potential].Die Anaesthesiologie · 2024Review
- Remimazolam for sedation in gastrointestinal endoscopy: A comprehensive review.World journal of gastrointestinal endoscopy · 2024Review
- Efficacy and safety of remimazolam besylate and ciprofol in painless gastrointestinal endoscopy in the elderly.Acta cirurgica brasileira · 2024Article
- Remimazolam in General Anesthesia: A Comprehensive Review of Its Applications and Clinical Efficacy.Drug design, development and therapy · 2024Review
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGastrointestinal endoscopy has been associated with difficult experiences and can leave patients with an unpleasant impression. Propofol and midazolam are the most commonly used intravenous anesthetics for sedation during gastrointestinal endoscopy. However, cardiac and pulmonary adverse events are the primary concerns associated with the use of these sedatives. Remimazolam tosylate is an ultra-short-acting benzodiazepine drug with a mild inhibitory effect on the respiratory and circulatory systems. These properties qualify remimazolam tosylate to be used as a replacement for propofol or midazolam as a sedative during gastrointestinal endoscopy. This study aims to describe the efficacy and safety of remimazolam tosylate as a sedative for upper gastrointestinal endoscopy.
methodsA multicenter, randomized, single-blind, parallel-controlled, noninferiority clinical study will be conducted to evaluate the efficacy and safety of remimazolam tosylate as a sedative during upper gastrointestinal endoscopy. Participants (n = 1800) will be randomized to receive remimazolam tosylate at 0.15 mg/kg (experimental group 1), remimazolam tosylate at 0.2 mg/kg (experimental group 2), or propofol at 1.5 mg/kg (control group). Procedure success will be assessed and defined as the completion of upper gastrointestinal endoscopy without the administration of a rescue sedative agent or more than two top-up doses of the trial drug in any 5-min period after initial administration. Sedation quality will be evaluated using the Modified Observer's Assessment of Alertness/Sedation score. Adverse events will be recorded to evaluate safety. DISCUSSION: This study will determine the optimal dosage of remimazolam tosylate during upper gastrointestinal endoscopy and will describe its efficacy and safety. These findings may contribute to a more comfortable and safer experience for patients compared with that when the conventional sedative propofol is used.
trial registrationClinicalTrials.gov NCT04727034. Registered on February 18, 2021.
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