A Phase 4 interventional study of Propofol, midazolam, fentanyl in Cognitive Impairment, sponsored by Melbourne Health. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-30.
Sponsored by Melbourne Health · Phase 4, Interventional, and Prevention
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.
A great variety of drug combinations are administered to patients having elective outpatient colonoscopy. In addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. This study aims to find drugs combinations that are associated with the least cognitive impairment.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 200 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Propofol, midazolam, fentanyl
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.
Drug: Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Also known as: Diprivan, Sublimase, Versed
Cognitive impairment at hospital discharge after elective outpatient colonoscopy
Time frame: Before discharge from daycare facility
Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care
Time frame: Before discharge from daycare facility
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Melbourne Health