Efficacy of Remimazolam with Fentanyl versus Midazolam with Fentanyl for sedation in screening colonoscopy: A randomized controlled study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503470-21-00

Acronym

REMI2023

Enrollment

200

Registered

2023-04-05

Start date

2023-08-25

Completion date

2023-12-23

Last updated

2023-08-28

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

Conditions

Screening patients

Brief summary

Total time from start of medication to fulfillment of the discharge criteria

Detailed description

Need for postprocedural recovery room, due to lack of fulfillment of discharge criteria., Patient discomfort/pain rated using NRS-11., Time to reach coecum., Need for additional Fentanyl., Need for additional sedativa., Patient satisfaction., Endoscopist satisfaction, Cognitive function at discharge.

Interventions

DRUGMidazolam hameln 5 mg/ml raztopina za injiciranje/infundiranje

DRUGByfavo 20 mg powder for solution for injection

DRUGFentanyl ”Hameln”

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Total time from start of medication to fulfillment of the discharge criteria	—

Secondary

Measure	Time frame
Need for postprocedural recovery room, due to lack of fulfillment of discharge criteria., Patient discomfort/pain rated using NRS-11., Time to reach coecum., Need for additional Fentanyl., Need for additional sedativa., Patient satisfaction., Endoscopist satisfaction, Cognitive function at discharge.	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026