Remimazolam vs Midazolam study

JRCT ID: jRCTs071240062

Registered date:26/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing upper gastrointestinal or colonoscopy with sedation.
• Date of first enrollment: 26/09/2024
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Remimazolam and midazolam sedation during gastrointestinal endoscopy

Outcome(s)

• Primary Outcome: The percentage of patients who have good ambulation in 5 minutes after endoscopy.

Secondary Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamaguchi Daisuke
• Source(s) of Monetary Support: Mundipharma K.K.