A Phase II/III Investigator Initiated Clinical Traial Evaluating the Efficacy and Safety of Remimazolam in Japanese Patients Undergoing Gastrointestinal Endoscopy

Phase 2

• Conditions: Japanese patients undergoing upper gastrointestinal endoscopy or colonoscopy without analgesics

• Registration Number: JPRN-jRCT2031200360
• Lead Sponsor: Ikehara Hisatomo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Dose-finding step
1The age at the time of obtaining consent is 20 to 74 years old
2 ASA classification is I or II
3 Weight 45kg or more and 70kg or less, BMI less than 30
Verification step
1 The age at the time of obtaining consent is 20 years or older
2 BMI is less than 30

Exclusion Criteria

Dose-finding step and verification step
1 Alcohol polydipsia (60g or more per day in terms of pure alcohol)
2 Those who regularly use benzodiazepines
3 Those who regularly use analgesics
4 Those with severe mental disease
5 Those with a history of abdominal surgery
6 Those with severe respiratory disease
7 SpO2 95% (room air)
8 Mallampati classification III or higher
9 Those with essential hypotension
10 Among the clinical test measurement values at the time of screening, those that correspond to any of the following
AST value: 2.5 times or more of the facility standard value upper limit
ALT value: 2.5 times or more of the upper limit of the facility standard value
Total bilirubin value: 1.5 times or more of the upper limit of facility standard value

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of sedation in gastrointestinal endoscopy<br>The percentage of subjects who meet the criteria for success in the analysis target population is defined as success when all of the following are satisfied.<br>1 Sedation (MOAA / S score 4 or less) can be obtained before the start of endoscopy.<br>2 Successful gastrointestinal endoscopy<br>3 The number of additional doses does not exceed 2 times per 6 minutes for upper gastrointestinal examination and 5 times per 15 minutes for colonoscopy.