Sedation Regimens in GI Endoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Endoscopy; Colonoscopy; Conscious Sedation
• Intervention / Treatment: Drug: midazolam alone

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

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
Adverse Events	Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted	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

Collaborators and Investigators

• Sponsor: Greg S Cohen MD LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: STU#: 00214212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No