Fentanyl Use for Sedation in Esophagogastroduodenoscopy

NCT ID: NCT01514695

Last Updated: 2013-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-12-31

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.

Conditions

Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fentanyl

Fentanyl arm

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.

Fentanyl

Intervention Type: DRUG

100mcg intravenously given in 2mL syringe at start of procedure

Placebo

Placebo of identical appearance

Group Type: PLACEBO_COMPARATOR

Midazolam

Intervention Type: DRUG

Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.

Placebo

Intervention Type: OTHER

One dose of saline (2ml)

Interventions

Midazolam

Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.

Intervention Type: DRUG

Fentanyl

100mcg intravenously given in 2mL syringe at start of procedure

Intervention Type: DRUG

Placebo

One dose of saline (2ml)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Khurram Khan

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khurram J Khan, MD, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

St Joseph's Healthcare Hamilton, McMaster University

Locations

St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

R.P. 11-3611

Identifier Type: -

Identifier Source: org_study_id