Early Phase 1
Completed N=300
Sedation Regimens in GI Endoscopy
Anesthesia · Endoscopy · Colonoscopy · Conscious Sedation
Source: ClinicalTrials.gov NCT04807101 ↗
Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Pain Felt During the Procedure — 0.29; 0.30 score on a scale
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.
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 | — |
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. Informational only — not medical advice.