Sedation Regimens in GI Endoscopy

  • End date
    Dec 6, 2023
  • participants needed
  • sponsor
    Greg S Cohen MD LLC
Updated on 6 August 2021
endoscopic surgery


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. English-speaking patients 18 years old and 75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.

Condition Anesthesia (Local), dental anesthesia, Endoscopy, anaesthesia, Anesthesia, moderate sedation, anesthesia procedures, endoscopic procedure, Conscious Sedation, sensory loss, endoscopic examination, colonoscopy, anesthesia for
Treatment midazolam alone
Clinical Study IdentifierNCT04807101
SponsorGreg S Cohen MD LLC
Last Modified on6 August 2021


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent
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