Early Phase 1
N=300
Sedation Regimens in GI Endoscopy
Anesthesia · Endoscopy · Colonoscopy · Conscious Sedation
Bottom Line
View on ClinicalTrials.gov: NCT04807101 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Pain Felt During the Procedure — 0.29; 0.30 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- midazolam alone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Greg S Cohen MD LLC
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Felt During the Procedure |
0.29; 0.30 | — |
| PRIMARY Adequacy of Sedation |
-0.28; -0.094 | — |
| SECONDARY Patient Reported Nausea |
1; 1 | — |
| SECONDARY Adverse Events |
1; 2 | — |
| SECONDARY Cecal Intubation Rate |
152; 148 | — |
| SECONDARY Cecal Intubation Time |
6.97; 7.99 | — |
| SECONDARY Colonoscopy Withdrawal Time |
16.44; 16.29 | — |
| SECONDARY Adenoma Detection Rate |
58; 54 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04807101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.