Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 8, 2007
CompletedFirst Posted
Study publicly available on registry
March 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedMay 30, 2013
May 1, 2013
1 year
March 8, 2007
May 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive impairment at hospital discharge after elective outpatient colonoscopy
Before discharge from daycare facility
Secondary Outcomes (1)
Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care
Before discharge from daycare facility
Study Arms (2)
1
ACTIVE COMPARATORThese patients will only receive intravenous propofol which will be titrated to an OAA/S score of 3. They will not receive fentanyl, midazolam or any other drugs
2
ACTIVE COMPARATORThese patients will receive propofol plus midazolam and/or fentanyl. Midazolam and fentanyl will be given in fixed doses first and propofol will be titrated to effect. All drugs will be given intravenously.
Interventions
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Eligibility Criteria
You may qualify if:
- Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation
You may not qualify if:
- No cognitive impairment
- Adequate English language comprehension
- Not combined with other procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
Study Sites (1)
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Related Publications (1)
Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17.
PMID: 19617584DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Leslie, MD
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2007
First Posted
March 12, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 30, 2013
Record last verified: 2013-05