Remimazolam vs Midazolam study (RECOVER Study)

Active, not recruiting

• Conditions: Patients undergoing upper gastrointestinal or colonoscopy with sedation.

• Registration Number: jRCTs071240062

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-26
• Last Update Posted: 2025-03-31

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients whose written consent was already obtained with free will.
2. Japanese patients between the ages of 18 and 80 years at the time of obtaining consent.
3. Patients scheduled to undergo upper gastrointestinal endoscopy or colonoscopy with sedation.

Exclusion Criteria

1. Patients scheduled to undergo endoscopic procedures.
2. Patients with a history of surgery on the upper and lower digestive tract.
3. Patients on dialysis.
4. Patients consuming more than 60 grams of alcohol per day.
5. Patients who have severe liver damage.
6. Patients with III/IV class of ASA-PS.
7. Patients who can not independently walk.
8. Patients who regularly use benzodiazepines, analgesics or central nervous system depressant.
9. Patients who have sedatives during 4 weeks before the time of obtaining consent.
10. Patients who have acute angle-closure glaucoma.
11. Patients who have myasthenia gravis.
12. Patients who are in pregnancy or under breast feeding.
13. Patients with a history of hypersensitivity to benzodiazepines or flumazenil, and patients with conditions or symptoms for which administration of these drugs is contraindicated.
14. Patients whom the investigator determines to be inappropriate for inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		The percentage of patients who have good ambulation in 5 minutes after endoscopy.

Secondary Outcome Measures

Name	Time	Method
The time until the start of endscopy (MOAA/S score under 4) from the start of sedation		The time until the start of endscopy (MOAA/S score under 4) from the start of sedation
The time until good ambulation (MOAA/S score 5) from the end of endoscopy		The time until good ambulation (MOAA/S score 5) from the end of endoscopy
Walking ability:The total time until good ambulation (MOAA/S score 5) from the end of endoscopy (include rest time for difficulty walking)		Walking ability:The total time until good ambulation (MOAA/S score 5) from the end of endoscopy (include rest time for difficulty walking)
Patient evaluation score: Patient satisfaction is rated on a 5-point scale from 1 to 5 using a survey form and recorded		Patient satisfaction is rated on a 5-point scale from 1 to 5 using a survey form and recorded
Success rate of sedation with MOAA/S score under 4 before endoscopy		Success rate of sedation with MOAA/S score under 4 before endoscopy
Remimazolam and midazolam doses required to obtain sedation (MOAA/S score under 4) prior to endoscopy		Remimazolam and midazolam doses required to obtain sedation (MOAA/S score under 4) prior to endoscopy
Total remimazolam and midazolam dose required to complete the endscopic procedure		Total remimazolam and midazolam dose required to complete the endscopic procedure
Physician evaluation score: Physician satisfaction is rated and recorded on a 5-point scale of 1 to 5 using the questionnaire		Physician satisfaction is rated and recorded on a 5-point scale of 1 to 5 using the questionnaire