Sedation Regimens in GI Endoscopy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807101
• Other study ID #: STU#: 00214212
• Status: Completed
• Phase: Early Phase 1
• Start date: April 5, 2021
• Est. completion date: July 10, 2023

Study information

• Verified date: October 2023
• Source: Greg S Cohen MD LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Colonoscopy
• Conscious Sedation
• Endoscopy

Intervention

Drug:
• midazolam alone
elimination of fentanyl from conscious sedation

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Greg S Cohen MD LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 day
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.	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?"	1 day
Secondary	Adverse Events	Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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