Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design

Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design - REMI-SATIS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061833

Enrollment

100

Registered

2026-06-08

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

digestive tract disorder

Interventions

1. Phase 1 (Pre-intervention / Midazolam use period) Duration: 3 weeks x 2 cycles (total 6 weeks) Target number: 50 patients Content: Midazolam will be used as the standard sedative, and data from

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for elective upper gastrointestinal endoscopy (screening) or colonoscopy (screening or cold polypectomy; CSP) 1. Men and women aged 20 years or older 2. Patients with an American Society of Anesthesiologists (ASA) preoperative condition classification of Class I to II 3. Patients who have given written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to benzodiazepine drugs. 2. Patients with severe hepatic impairment (Child-Pugh class C) or those requiring dialysis. 3. Patients with ASA classification III or higher. 4. Patients with drug dependence, organic brain damage, or diseases related to upper airway obstruction (e.g., severe obesity, micrognathia, tonsillar hypertrophy, sleep apnea syndrome). 5. Pregnant, breastfeeding, or potentially pregnant women. 6. Patients requiring emergency endoscopy. 7. Patients scheduled for procedures requiring hospitalization, such as endoscopic mucosal resection (EMR). 8. Other patients deemed unsuitable as research subjects by the attending physician.

Design outcomes

Primary

Measure	Time frame
The average values for the following patient satisfaction items 1-6. (5-point scale: 1: Very dissatisfied, 2: Dissatisfied, 3: Neutral, 4: Satisfied, 5: Very satisfied) 1.Time from the start of drug administration to the onset of sedation 2.Satisfaction with the reduction of discomfort during the examination 3.Depth of sedation during the examination 4.Time spent awake after the examination 5.Would you like to use this drug again? 6.Amnesia during endoscopy	—

Measure

Time frame

The average values for the following patient satisfaction items 1-6. (5-point scale: 1: Very dissatisfied, 2: Dissatisfied, 3: Neutral, 4: Satisfied, 5: Very satisfied) 1.Time from the start of drug administration to the onset of sedation 2.Satisfaction with the reduction of discomfort during the examination 3.Depth of sedation during the examination 4.Time spent awake after the examination 5.Would you like to use this drug again? 6.Amnesia during endoscopy

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Countries

Japan

Contacts

Public ContactUESUGI ATSUSHI

National Hospital Organization Hokkaido Cancer Center Gastroenterology

uesugi.atsushi.ke@mail.hosp.go.jp0118119111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026