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Clinical Trials/2023-503470-21-00
2023-503470-21-00
Completed
Phase 4

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

Herlev Hospital1 site in 1 country200 target enrollmentStarted: April 5, 2023Last updated:
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Overview

Phase
Phase 4
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Total time from start of medication to fulfillment of the discharge criteria
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The overall object of this project is to investigate Remimazolam with Fentanyl compared to Midazolam with Fentanyl for sedation in screening colonoscopy with the primary outcome being total time from start of medication to fulfillment of the discharge criteria. In this way we will examine whether Remimazolam with Fentanyl could create an improvement in procedural sedation by leading to both a shorter procedure as well as shorter recovery time.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age over 18
  • •Scheduled for elective colonoscopy screening for colon cancer
  • •Must be able to provide informed written consent.

Exclusion Criteria

  • •Requiring general anesthesia.
  • •Allergy to Midazolam, Remimazolam, opioids or ingredients.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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.

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Andrea Ambrecht

Scientific

Herlev Hospital

Study Sites (1)

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