Sedation Regimens in GI Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Study of Midazolam and Fentanyl Versus Midazolam Alone for Sedation in Gastrointestinal Endoscopy

Conditions
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Anesthesia, Endoscopy, Colonoscopy, Conscious Sedation

Intervention / Treatment
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* Drug: midazolam alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: midazolam and fentanyl<br>Patients in this arm will receive standard conscious sedation with midazolam and fentanyl | |
| Experimental: midazolam alone<br>Patients in this arm will receive conscious sedation with medazepam alone | Drug: midazolam alone<br>* elimination of fentanyl from conscious sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Difference in pain pre and post procedure | Difference in level of pain felt prior to the procedure versus after 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 rate the level of pain felt prior to the procedure and after the procedure, using 2 visual analog scales both ranging from 0 to 10 with higher numbers indicating more pain. The pain score for prior to the procedure will be subtracted from the pain score for after the procedure with the resulting number giving a score for the difference in pain pre and post procedure. A positive number indicates more pain post procedure and a negative number indicates less pain post procedure. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Nurse Reported Nausea | Nurse reported nausea as assessed by a yes or no answer to the question Did the patient report any nausea during recovery? | 1 day | 
| Nurse reported pain | Nurse reported pain as assessed by a yes or no answer to the question Did the patient report any pain during recovery? | 1 day | 
| O2 desaturation during procedure | Nurse reported O2 desaturation as assessed by a yes or no answer to the question Any episodes of O2 desaturation less than 90% or leading to intervention? | 1 day | 
| Hypotension during procedure | Nurse reported hypotension as assessed by a yes or no answer to the question Any problematic changes in heart rate or blood pressure during intervention? (eg, systolic blood pressure < 90, > 160; heart rate < 50, > 120) | 1 day | 
| Hemodynamic or respiratory issues during procedure | Nurse reported hemodynamic or respiratory issues as assessed by a yes or no answer to the question Any hemodynamic or respiratory conditions that interrupted the procedure? | 1 day | 
| Physician reported patient cooperation during the procedure | Physicians will rate the patient's cooperation by choosing one of the following options: (1) procedure aborted due to lack of cooperation (2) procedure delayed/interrupted due to lack of cooperation (3) adequately cooperative | 1 day | 
| Physician reported patient discomfort during the procedure | Physicians will answer the following yes or no question: Was the exam interrupted in any way due to patient discomfort? | 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 |