A Randomized Study of Midazolam and Fentanyl Versus Midazolam Alone for Sedation in Gastrointestinal Endoscopy
| Registry | NCT04807101 |
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| Status | Completed |
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| Phase | Early Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 300 (Actual) |
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| Sponsor | Greg S Cohen MD LLC (Other) |
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| Conditions | Anesthesia, Endoscopy, Colonoscopy, Conscious Sedation |
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| Interventions | midazolam alone (Drug) |
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| Dates | start 2021-04-05, primary completion 2023-07-10, completion 2023-07-10, first posted 2021-03-19, last updated 2024-04-15 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| midazolam and fentanyl | No intervention | | Patients in this arm will receive standard conscious sedation with midazolam and fentanyl |
| midazolam alone | Experimental | Drug: midazolam alone | Patients in this arm will receive conscious sedation with medazepam alone |
- midazolam alone (Drug): elimination of fentanyl from conscious sedation
+Outcome measures
Primary outcomes
- Pain Felt During the Procedure [1 day]: 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.
- Adequacy of Sedation [1 day]: 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.
Secondary outcomes
- Patient Reported Nausea [1 day]: Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?"
- Adverse Events [1 day]: Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
- Cecal Intubation Rate [through study completion, an average of 1 year]: cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review
- Cecal Intubation Time [through study completion, an average of 1 year]: time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review
- Colonoscopy Withdrawal Time [through study completion, an average of 1 year]: Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review
- Adenoma Detection Rate [through study completion, an average of 1 year]: Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review
+Eligibility
Sex: All, ages: 18 Years to 75 Years, 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
+Posted results
Participant flow
| Milestone | Midazolam and Fentanyl | Midazolam Alone |
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| Started | 152 | 148 |
| Completed | 152 | 148 |
| Not completed | 0 | 0 |
Outcome results
- Pain Felt During the Procedure (Primary), Mean, score on a scale: Midazolam and Fentanyl 0.29 +/- 1.2; Midazolam Alone 0.30 +/- 1.1
- Adequacy of Sedation (Primary), Mean, score on a scale: Midazolam and Fentanyl -0.28 +/- 0.94; Midazolam Alone -0.094 +/- 0.78
- Patient Reported Nausea (Secondary), Count of participants, Participants: Midazolam and Fentanyl 1; Midazolam Alone 1
- Adverse Events (Secondary), Count of participants, Participants: Midazolam and Fentanyl 1; Midazolam Alone 2
- Cecal Intubation Rate (Secondary), Count of participants, Participants: Midazolam and Fentanyl 152; Midazolam Alone 148
- Cecal Intubation Time (Secondary), Mean, minutes: Midazolam and Fentanyl 6.97 +/- 3.10; Midazolam Alone 7.99 +/- 3.66
- Colonoscopy Withdrawal Time (Secondary), Mean, minutes: Midazolam and Fentanyl 16.44 +/- 4.01; Midazolam Alone 16.29 +/- 4.34
- Adenoma Detection Rate (Secondary), Count of participants, Participants: Midazolam and Fentanyl 58; Midazolam Alone 54
Adverse events
Time frame: 1 day
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Midazolam and Fentanyl | 0/152 (0.0%) | 0/152 (0.0%) | 1/152 (0.7%) |
| Midazolam Alone | 0/148 (0.0%) | 0/148 (0.0%) | 2/148 (1.4%) |
Other adverse events by term
| Term | Organ system | Midazolam and Fentanyl | Midazolam Alone |
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| procedure interrupted due to pain | General disorders | 1/152 | 2/148 |
+Locations (1)
| Facility | City | Country | Status |
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| Northwestern Memorial Hospital | Chicago, Illinois | United States | |
+Study documents