Sedation Regimens in GI Endoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2023-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

NCT06763705

Deep Sedations Conscious Sedation Colonoscopy

RECRUITING PHASE4

The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

NCT00376831

Colonoscopy Conscious Sedation

COMPLETED PHASE4

Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy

NCT01145222

Sedation

COMPLETED PHASE2

Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy

NCT01769586

Sedation Endoscopy

COMPLETED NA

Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy

NCT03803449

Patient Satisfaction

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Endoscopy Colonoscopy Conscious Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

midazolam and fentanyl

Patients in this arm will receive standard conscious sedation with midazolam and fentanyl

Group Type NO_INTERVENTION

No interventions assigned to this group

midazolam alone

Patients in this arm will receive conscious sedation with medazepam alone

Group Type EXPERIMENTAL

midazolam alone

Intervention Type DRUG

elimination of fentanyl from conscious sedation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

midazolam alone

elimination of fentanyl from conscious sedation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes