Japanese patients undergoing upper gastrointestinal endoscopy or colonoscopy without analgesics
Conditions
Interventions
Dose-finding step
Remimazolam is administered at the following doses
Cohort 1: Initial dose 2 mg Additional dose 1 mg / dose
Cohort 2: Initial dose 3 mg Additional dose 1 mg / dose
Cohort 3: Initial d
Sponsors
Ikehara Hisatomo
Mundipharma K.K
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of sedation in gastrointestinal endoscopy 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. 1 Sedation (MOAA / S score 4 or less) can be obtained before the start of endoscopy. 2 Successful gastrointestinal endoscopy 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness 1 Percentage of subjects who achieved sedation (MOAA / S score of 4 or less) before the start of endoscopy 2 Time from initial administration of investigational drug to sedation (MOAA / S score of 4 or less) Optimal dose of investigational drug until sedation (MOAA / S score of 4 or less) is obtained (total of initial dose and additional dose) 4 Time from the end of the endoscope to walking (walking without swaying a 5m straight line) 5 Time from the final administration of the investigational drug to walking (walking without swaying a 5 m straight line) 6 Patient satisfaction evaluation (5-grade evaluation) 7 Satisfaction evaluation by doctor (5-grade evaluation) Safety assessment 1. Adverse events 2. Laboratory tests (hematological tests, blood biochemical tests and urine tests) 3. Vital signs (blood pressure, heart rate, respiratory rate), SpO2 4. ECG examination (12-lead ECG, monitor ECG) 5. Presence or absence of vascular pain 6. Evaluation of arousal (presence or absence of resedation after awakening [from the end of investigational drug administration to the time of leaving the room], presence or absence of wobbling / falling [from after leaving the room to returning home / from returning home to going to bed]) 7. With or without urgent flumazenil administration 8. Presence or absence of resedation in patients receiving flumazenil 9. Presence or absence of loss of consciousness 10. With or without oxygen administration 11. Whether or not manual ventilation is performed 12. Whether or not an emergency response is provided by a doctor other than the endoscopist | — |
Contacts
Public ContactRyoji Ichijima
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan
Outcome results
None listed