Endoscopy Clinical Trial
— FUSEOfficial 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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St Joseph's Healthcare Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Joseph's Healthcare Hamilton | McMaster University |
Canada,
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 |
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