臨床研究等提出・公開システム

Comparative study on the efficacy and recovery of Remimazolam and Midazolam in the sedation for the patients undergoing gastrointestinal endoscopy (RECOVER Study)

Remimazolam vs Midazolam study (RECOVER Study)

Yamaguchi Daisuke

Saga University Hospital

5-1-1 Nabeshima, Saga city, Saga Japan

daisukehawks@gmail.com

Yamaguchi Daisuke

Saga University Hospital

5-1-1 Nabeshima, Saga city, Saga Japan

+81-952-34-2361

daisukehawks@gmail.com

Not Recruiting

Sept. 26, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Both

Patients undergoing upper gastrointestinal or colonoscopy with sedation.

Remimazolam and midazolam sedation during gastrointestinal endoscopy

Upper gastrointestinal endoscopy, Colonoscopy

remimazolam, midazolam

D004724

D004724

The percentage of patients who have good ambulation in 5 minutes after endoscopy.

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

+81-952-34-3357

July. 10, 2024

none