Sedation Regimens in GI Endoscopy

NCT04807101 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: STU#: 00214212
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Anesthesia; Endoscopy; Colonoscopy; Conscious Sedation

Outcome Measures

Primary Outcomes (2)

• Pain Felt During the Procedure

  Level of discomfort during the procedure as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "How much discomfort did you experience during the procedure?" A visual analog scale will be used ranging from 0 to 10 with higher numbers indicating more pain.

  1 day

• Adequacy of Sedation

  Adequacy of sedation as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "If having this procedure again in the future, how much sedation would you prefer to have?" A visual analog scale will be used ranging from -5 to 5, with lower numbers indicating a preference for less sedation in the future and higher numbers indicating a preference for more sedation in the future.

  1 day

Secondary Outcomes (6)

• Patient Reported Nausea

  1 day

• Adverse Events

  1 day

• Cecal Intubation Rate

  through study completion, an average of 1 year

• Cecal Intubation Time

  through study completion, an average of 1 year

• Colonoscopy Withdrawal Time

  through study completion, an average of 1 year

Study Arms (2)

midazolam and fentanyl

NO INTERVENTION

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

midazolam alone

EXPERIMENTAL

Patients in this arm will receive conscious sedation with medazepam alone

Drug: midazolam alone

Interventions

midazolam alone DRUG

elimination of fentanyl from conscious sedation

midazolam alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Greg S Cohen MD LLC: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Greg Cohen, MD
• Organization: Northwestern University

gregcohen@northwestern.edu

312-695-4452

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 19, 2021
• Study Start: April 5, 2021
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2023-10

Locations

US (1)