Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations

This study is currently recruiting participants.

Verified by Melbourne Health, March 2007

Sponsored by:	Melbourne Health
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00446420

Purpose

Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects.

200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.

Condition	Intervention
Cognitive Impairment	Drug: Propofol, midazolam, fentanyl

Drug Information available for: Fentanyl Citrate Fentanyl Midazolam Midazolam hydrochloride Midazolam maleate Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

Cognitive impairment at hospital discharge after elective outpatient colonoscopy

Secondary Outcome Measures:

Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation

Exclusion Criteria:

No cognitive impairment
Adequate English language comprehension
Not combined with other procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446420

Locations

Australia, Victoria
Royal Melbourne Hospital	Recruiting
Parkville, Victoria, Australia, 3050
Contact: Kate Leslie, MD 61-3-93427000 kate.leslie@mh.org.au
Principal Investigator: Kate Leslie, MD
Sub-Investigator: Usha Padmanabhan, MD
Sub-Investigator: Brendan Silbert, MD

Sponsors and Collaborators

Melbourne Health

Investigators

Principal Investigator:

Kate Leslie, MD

Melbourne Health

More Information

Study ID Numbers:	2006.228
Study First Received:	March 8, 2007
Last Updated:	March 8, 2007
ClinicalTrials.gov Identifier:	NCT00446420
Health Authority:	Australia: Human Research Ethics Committee

Study placed in the following topic categories:

Fentanyl
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Propofol

Midazolam
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Pharmacologic Actions

Adjuvants, Anesthesia
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009