Fentanyl Use for Sedation in Esophagogastroduodenoscopy

Phase 4

Completed

• Conditions: Endoscopy
• Interventions: Drug: Midazolam; Other: Placebo; Drug: Fentanyl

• Registration Number: NCT01514695
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-23
• Study Start: 2012-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• outpatient elective upper endoscopy
• age 18-65
• able to give consent

Exclusion Criteria

• mental incompetency
• pregnancy
• weight <55kg or 110 lbs
• emergent procedures,
• known hypersensitivity or allergy to fentanyl or midazolam
• chronic use of benzodiazepines or opioids
• patients known a priori to require therapeutic interventions in conjunction with their EGD
• patients to have major cardiorespiratory comorbidities, obstructive sleep apnea, liver cirrhosis, or renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo of identical appearance
Fentanyl	Midazolam	Fentanyl arm
Fentanyl	Fentanyl	Fentanyl arm
Placebo	Midazolam	Placebo of identical appearance

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale	Within 72 hours of procedure	Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.

Secondary Outcome Measures

Name	Time	Method
Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale	Following procedure up to time of discharge (average of 45 minutes after procedure started)
Patient willingness to repeat procedure	Asked within 72 hours of procedure
Presence of significant retching	Following procedure up to time of discharge (average of 45 minutes after procedure started)	Recorded by physician completing procedure
Presence of adverse events	Following procedure up to time of discharge (average of 45 minutes after procedure started)	Any adverse event during procedure up until patient leaves endoscopy unit

Trial Locations

Locations (1)

St Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada