Endoscopy Clinical Trial
Official title:
Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE): a Phase 4, Randomized, Double-blind, Placebo-controlled Trial of Fentanyl Added to Midazolam Compared to Midazolam Alone for Sedation in Routine Upper Endoscopy
The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure.
Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into the intestines. It is a routine test and considered very safe. However, patients can experience discomfort from air insufflation in the stomach and unpleasantness due to gagging during the procedure. Conscious sedation with medications like sedatives and narcotics are used to improve patient satisfaction and enhance physician ability to perform an optimal examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist and the goal is always to use the lowest dose possible to achieve the best examination. Combination therapy (with a sedative & narcotic) may increase the adverse effect profile compared to a sedative alone and not improve the overall experience of the physician or patient. The goal of our study is to assess in randomized, double-blind, placebo controlled study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation compared to a sedative (midazolam) alone. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03298776 -
I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions
|
N/A | |
Completed |
NCT02887378 -
Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps
|
N/A | |
Recruiting |
NCT01627171 -
Colonoscopy Preparation Optimization for INpatients- COIN Study
|
Phase 4 | |
Completed |
NCT02350933 -
Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation
|
N/A | |
Completed |
NCT00671177 -
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
|
N/A | |
Completed |
NCT06033729 -
Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA
|
N/A | |
Withdrawn |
NCT04983498 -
Enhanced Recovery Pathway for Endoscopy
|
Phase 4 | |
Enrolling by invitation |
NCT04719117 -
Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
|
||
Completed |
NCT03369197 -
Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
|
N/A | |
Completed |
NCT04186390 -
Learning Small Bowel Capsule Endoscopy
|
||
Completed |
NCT02714699 -
Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy
|
Phase 2/Phase 3 | |
Completed |
NCT00614159 -
Ketamine Compared to Propofol for Pediatric GI Endoscopy
|
N/A | |
Completed |
NCT04072328 -
Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
|
Phase 2 | |
Completed |
NCT04150237 -
Using Simulation to Ensure Basic Competence in Gastroscopy
|
||
Completed |
NCT03287687 -
Safety and Efficacy of CO2 for Endoscopy
|
Phase 4 | |
Not yet recruiting |
NCT03351790 -
Endoscopy Quality Study
|
N/A | |
Completed |
NCT04541667 -
Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
|
N/A | |
Active, not recruiting |
NCT06168682 -
Nasal CPAP - The Treatment IMpact on Oxygenation in High-risk Patients During Deep Sedation for Endoscopy
|
N/A | |
Recruiting |
NCT05479253 -
AI-assisted Endoscopy Report System In Improving Reporting Quality
|
N/A | |
Recruiting |
NCT04903444 -
Development and Validation of an Artificial Intelligence-based Biliary Stricture Navigation System in MRCP-based ERCP
|
N/A |