drugset / Trial / NCT00446420

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

NCT00446420 ↗

Phase 4 Completed 200 enrolled Melbourne Health
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2007-02
Primary completion
2008-02
Completion
2008-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 50 ug Intravenous
Comparator Midazolam Small molecule 2 mg Intravenous
Comparator Propofol Small molecule — Intravenous

Indications