Sedation Regimens in GI Endoscopy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: midazolam and fentanyl Patients in this arm will receive standard conscious sedation with midazolam and fentanyl |
|
| Experimental: midazolam alone Patients in this arm will receive conscious sedation with medazepam alone |
Drug: midazolam alone
elimination of fentanyl from conscious sedation
|
Outcome Measures
Primary Outcome Measures
- 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.
- Difference in pain pre and post procedure [1 day]
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.
Secondary Outcome Measures
- 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?"
- Nurse Reported Nausea [1 day]
Nurse reported nausea as assessed by a yes or no answer to the question "Did the patient report any nausea during recovery?"
- Nurse reported pain [1 day]
Nurse reported pain as assessed by a yes or no answer to the question "Did the patient report any pain during recovery?"
- O2 desaturation during procedure [1 day]
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?"
- Hypotension during procedure [1 day]
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)"
- Hemodynamic or respiratory issues during procedure [1 day]
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?"
- Physician reported patient cooperation during the procedure [1 day]
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
- Physician reported patient discomfort during the procedure [1 day]
Physicians will answer the following yes or no question: "Was the exam interrupted in any way due to patient discomfort?"
- 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 Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Greg S Cohen MD LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU#: 00214212