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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam alone | Drug | elimination of fentanyl from conscious sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Nausea | Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?" | 1 day |
| Adverse Events | Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam and Fentanyl | Patients in this arm will receive standard conscious sedation with midazolam and fentanyl |
| FG001 | Midazolam Alone | Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam and Fentanyl | Patients in this arm will receive standard conscious sedation with midazolam and fentanyl |
| BG001 | Midazolam Alone | Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
1 day
oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midazolam and Fentanyl | Patients in this arm will receive standard conscious sedation with midazolam and fentanyl |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| procedure interrupted due to pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Cohen, MD | Northwestern University | 312-695-4452 | gregcohen@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2021 | Oct 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 1 day |
| Cecal Intubation Rate | cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review | through study completion, an average of 1 year |
| Cecal Intubation Time | time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review | through study completion, an average of 1 year |
| Colonoscopy Withdrawal Time | Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review | through study completion, an average of 1 year |
| Adenoma Detection Rate | Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review | through study completion, an average of 1 year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
|
| Secondary | Patient Reported Nausea | Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?" | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Adverse Events | Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Cecal Intubation Rate | cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
|
| Secondary | Cecal Intubation Time | time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review | Posted | Mean | Standard Deviation | minutes | through study completion, an average of 1 year |
|
|
|
| Secondary | Colonoscopy Withdrawal Time | Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review | Posted | Mean | Standard Deviation | minutes | through study completion, an average of 1 year |
|
|
|
| Secondary | Adenoma Detection Rate | Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
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| 0 |
| 152 |
| 0 |
| 152 |
| 1 |
| 152 |
| EG001 | Midazolam Alone | Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation | 0 | 148 | 0 | 148 | 2 | 148 |
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| D006571 | Heterocyclic Compounds |