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Comparison of Sedation Outcomes and Discharge Criteria Between Remimazolam and Flunitrazepam in Outpatient Gastrointestinal Endoscopy: A Prospective Observational Study

Comparison of Sedation Outcomes and Discharge Criteria Between Remimazolam and Flunitrazepam in Outpatient Gastrointestinal Endoscopy: A Prospective Observational Study - Remimazolam vs flunitrazepam for sedation in outpatient gastrointestinal endoscopy: time to discharge based on standardized discharge criteria (prospective observational study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061099
Enrollment
140
Registered
2026-03-30
Start date
2025-11-19
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

Gastrointestinal diseases requiring upper or lower endoscopy (e.g., gastroesophageal reflux disease, atrophic gastritis, gastric cancer, colorectal cancer, colorectal polyps)

Interventions

None listed

Sponsors

Imagawa Medical Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive participants aged >= 18 years undergoing upper gastrointestinal endoscopy (EGD) or colonoscopy (CS) under sedation at our clinic who provide written informed consent to this study.

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to the study drugs Poor general condition classified as ASA Physical Status Class IV or V Pregnancy or breastfeeding Severe COPD or obstructive sleep apnea; severe hepatic impairment (e.g., Child-Pugh C); chronic benzodiazepine use or tolerance; severe renal impairment (eGFR < 30 mL/min/1.73 m^2) Unable or unwilling to provide written informed consent to this study

Design outcomes

Primary

MeasureTime frame
Time (minutes) from end of endoscopy to discharge readiness (first attainment of PADSS>9/10)

Secondary

MeasureTime frame
Compare sedation drug use and the frequency of sedation-related adverse events (SBP <90 mmHg,SpO2 <90%, HR <50 bpm, oxygen supplementation), including whether interventions were required.

Countries

Japan

Contacts

Public ContactAtsushi Imagawa

Imagawa Medical Clinic Gastroenterology

imagawa-gi@nifty.com+81-875-62-2052

Outcome results

None listed

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