Sedation Regimens in GI Endoscopy

Greg S Cohen MD LLC

Status and phase: Completed; Early Phase 1

Conditions: Conscious Sedation; Colonoscopy; Endoscopy; Anesthesia

Treatments: Drug: midazolam alone

Study type: Interventional

Funder types: Other

Identifiers

NCT04807101

STU#: 00214212

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

midazolam and fentanyl

No Intervention group

Description:

Patients in this arm will receive standard conscious sedation with midazolam and fentanyl

midazolam alone

Experimental group

Description:

Patients in this arm will receive conscious sedation with medazepam alone

Treatment:

Drug: midazolam alone