Status:
COMPLETED
Sedation Regimens in GI Endoscopy
Lead Sponsor:
Greg S Cohen MD LLC
Conditions:
Anesthesia
Endoscopy
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. Eng...
Eligibility Criteria
Inclusion
- English-speaking patients
- Patients ≥18 years old and ≤75 years old
- Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl
- Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure
Exclusion
- Patients with an allergy or prior adverse event to either fentanyl or midazolam
- Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04807101
Start Date
April 5 2021
End Date
July 10 2023
Last Update
April 15 2024
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611