Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE)

• ClinicalTrials.gov Identifier: NCT01514695
• Recruitment Status: Completed
• First Posted: January 23, 2012
• Last Update Posted: January 30, 2013
• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborator: McMaster University
• Information provided by (Responsible Party): Khurram Khan, St. Joseph's Healthcare Hamilton

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Endoscopy	Drug: Midazolam; Drug: Fentanyl; Other: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: February 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fentanyl; Fentanyl arm	Drug: Midazolam; Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.; Drug: Fentanyl; 100mcg intravenously given in 2mL syringe at start of procedure
Placebo Comparator: Placebo; Placebo of identical appearance	Drug: Midazolam; Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.; Other: Placebo; One dose of saline (2ml)

Outcome Measures

Primary Outcome Measures :

1. Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale [ Time Frame: 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 :

1. Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale [ Time Frame: Following procedure up to time of discharge (average of 45 minutes after procedure started) ]
2. Patient willingness to repeat procedure [ Time Frame: Asked within 72 hours of procedure ]
3. Presence of significant retching [ Time Frame: Following procedure up to time of discharge (average of 45 minutes after procedure started) ]
   Recorded by physician completing procedure
4. Presence of adverse events [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N4A6

Sponsors and Collaborators

St. Joseph's Healthcare Hamilton

McMaster University

Investigators

• Principal Investigator: Khurram J Khan, MD, BSc, MSc; St Joseph's Healthcare Hamilton, McMaster University

More Information

• Responsible Party: Khurram Khan, Assistant Professor of Medicine, St. Joseph's Healthcare Hamilton
• ClinicalTrials.gov Identifier: NCT01514695
• Other Study ID Numbers: R.P. 11-3611
• First Posted: January 23, 2012
• Last Update Posted: January 30, 2013
• Last Verified: January 2013

Keywords provided by Khurram Khan, St. Joseph's Healthcare Hamilton:

endoscopy; sedation; opioid; narcotic

Additional relevant MeSH terms:

Fentanyl; Midazolam; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action