Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sedation Regimens in GI Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04807101
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Greg Cohen, Greg S Cohen MD LLC

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Anesthesia Endoscopy Colonoscopy Conscious Sedation Drug: midazolam alone Early Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study of Midazolam and Fentanyl Versus Midazolam Alone for Sedation in Gastrointestinal Endoscopy
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Difference in pain pre and post procedure [ Time Frame: 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 :
  1. 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?"

  2. Nurse Reported Nausea [ Time Frame: 1 day ]
    Nurse reported nausea as assessed by a yes or no answer to the question "Did the patient report any nausea during recovery?"

  3. Nurse reported pain [ Time Frame: 1 day ]
    Nurse reported pain as assessed by a yes or no answer to the question "Did the patient report any pain during recovery?"

  4. O2 desaturation during procedure [ Time Frame: 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?"

  5. Hypotension during procedure [ Time Frame: 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)"

  6. Hemodynamic or respiratory issues during procedure [ Time Frame: 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?"

  7. Physician reported patient cooperation during the procedure [ Time Frame: 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

  8. Physician reported patient discomfort during the procedure [ Time Frame: 1 day ]
    Physicians will answer the following yes or no question: "Was the exam interrupted in any way due to patient discomfort?"

  9. 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

  10. 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

  11. 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

  12. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807101


Contacts
Layout table for location contacts
Contact: Greg Cohen 3126954452 gcohenmd@gmail.com

Locations
Layout table for location information
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Greg Cohen    312-695-4452    gcohenmd@gmail.com   
Sponsors and Collaborators
Greg S Cohen MD LLC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Greg Cohen, Clinical Associate Professor of Medicine, Greg S Cohen MD LLC
ClinicalTrials.gov Identifier: NCT04807101    
Other Study ID Numbers: STU#: 00214212
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action