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NCT Number: NCT04807101

Sedation Regimens in GI 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.

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Key information

Conditions

Anesthesia Colonoscopy Conscious Sedation Endoscopy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam alone

Drug

elimination of fentanyl from conscious sedation

Primary outcomes

  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.

Secondary outcomes

  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. Adverse Events

    Time frame: 1 day

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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Greg S Cohen MD LLC

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2021
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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