Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
NCT ID: NCT00446420
Last Updated: 2013-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2007-02-28
2008-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
These 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
Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
2
These 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.
Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Interventions
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Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Adequate English language comprehension
* Not combined with other procedures
18 Years
ALL
No
Sponsors
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Melbourne Health
OTHER
Responsible Party
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Principal Investigators
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Kate Leslie, MD
Role: PRINCIPAL_INVESTIGATOR
Melbourne Health
Locations
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Royal Melbourne Hospital
Parkville, Victoria, Australia
Countries
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References
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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.
Other Identifiers
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2006.228
Identifier Type: -
Identifier Source: org_study_id
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