First dose-ranging study of remimazolam in Japanese patients undergoing gastrointestinal endoscopy: Phase II investigator-initiated clinical trial.
Japan
colonoscopy
remimazolam
upper gastrointestinal endoscopy
Journal
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society
ISSN: 1443-1661
Titre abrégé: Dig Endosc
Pays: Australia
ID NLM: 9101419
Informations de publication
Date de publication:
Nov 2022
Nov 2022
Historique:
received:
19
03
2022
accepted:
24
05
2022
pubmed:
26
5
2022
medline:
11
11
2022
entrez:
25
5
2022
Statut:
ppublish
Résumé
Remimazolam, an ultra-short-acting benzodiazepine, has been used for procedural sedation in the United States. We conducted an investigator-initiated clinical trial to determine the appropriate dose of remimazolam required for sedation during gastrointestinal endoscopy in Japanese subjects. In this single-center, open-label, uncontrolled, phase II trial, a three-stage cohort investigated the appropriate initial and additional doses of remimazolam required for gastrointestinal endoscopy. This study was designed with advice from the Pharmaceuticals and Medical Devices Agency. The initial and additional doses were 2 mg and 1 mg/dose, 3 mg and 1 mg/dose, and 5 mg and 2 mg/dose in cohorts 1, 2, and 3, respectively. Each cohort included 10 cases of upper gastrointestinal endoscopy and colonoscopy. The primary end-point was the success rate of sedation during gastrointestinal endoscopy. Sedation was successful in all gastrointestinal endoscopies in cohorts 1 and 2. In cohort 1, sedation was achieved in five (25.0%) and 10 (50.0%) participants with the initial dose and total dose (initial dose + additional dose ≤ the initial dose of the next cohort), respectively, before endoscopy. In cohort 2, sedation was achieved in 11 (55.0%) and 18 (90.0%) participants with the initial dose and total dose, respectively, before endoscopy. No patient in either cohort lost consciousness or required flumazenil or manual ventilation. Initial and additional doses of 3 mg and 1 mg/dose of remimazolam, respectively, were shown to be effective and safe for sedation during gastrointestinal endoscopy in Japanese patients.
Substances chimiques
remimazolam
7V4A8U16MB
Hypnotics and Sedatives
0
Benzodiazepines
12794-10-4
Types de publication
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1403-1412Subventions
Organisme : Mundy Pharma Co., Ltd.
Informations de copyright
© 2022 Japan Gastroenterological Endoscopy Society.
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