Fentanyl Use for Sedation in Esophagogastroduodenoscopy

Endoscopy Clinical Trial

— FUSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514695
• Other study ID #: R.P. 11-3611
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2012
• Last updated: January 28, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endoscopy

Intervention

Drug:
• Midazolam
Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.
• Fentanyl
100mcg intravenously given in 2mL syringe at start of procedure

Other:
• Placebo
One dose of saline (2ml)

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale	Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.	Within 72 hours of procedure	No
Secondary	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)	No
Secondary	Patient willingness to repeat procedure		Asked within 72 hours of procedure	Yes
Secondary	Presence of significant retching	Recorded by physician completing procedure	Following procedure up to time of discharge (average of 45 minutes after procedure started)	No
Secondary	Presence of adverse events	Any adverse event during procedure up until patient leaves endoscopy unit	Following procedure up to time of discharge (average of 45 minutes after procedure started)	Yes