Fentanyl Use for Sedation in Esophagogastroduodenoscopy

NCT01514695 | Completed Phase 4

• 1 other identifier: R.P. 11-3611
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopy

Keywords

endoscopy; sedation; opioid; narcotic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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)

• Presence of adverse events

  Following procedure up to time of discharge (average of 45 minutes after procedure started)

Study Arms (2)

Fentanyl

EXPERIMENTAL

Fentanyl arm

Drug: Midazolam; Drug: Fentanyl

Placebo

PLACEBO COMPARATOR

Placebo of identical appearance

Drug: Midazolam; Other: Placebo

Interventions

Midazolam DRUG

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

Fentanyl; Placebo

Fentanyl DRUG

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

Fentanyl

Placebo OTHER

One dose of saline (2ml)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

Location

MeSH Terms

Interventions

Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Khurram J Khan, MD, BSc, MSc

  St Joseph's Healthcare Hamilton, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 23, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

CA (1)