Sedation Regimens in GI Endoscopy

October 6, 2023 updated by: Greg Cohen, Greg S Cohen MD LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Felt During the Procedure
Time Frame: 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.
1 day
Adequacy of Sedation
Time Frame: 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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Reported Nausea
Time Frame: 1 day
Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?"
1 day
Adverse Events
Time Frame: 1 day
Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
1 day
Cecal Intubation Rate
Time Frame: 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
through study completion, an average of 1 year
Cecal Intubation Time
Time Frame: 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
through study completion, an average of 1 year
Colonoscopy Withdrawal Time
Time Frame: 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
through study completion, an average of 1 year
Adenoma Detection Rate
Time Frame: 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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Greg S Cohen MD LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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