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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Melbourne Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00446420
First received: March 8, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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

No publications provided by Melbourne Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Midazolam
Fentanyl
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013