Clinical Trials Directory

Trials / Completed

CompletedNCT00446420

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
200 (actual)
Sponsor
Melbourne Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGPropofol, midazolam, fentanylAll drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy

Timeline

Start date
2007-02-01
Primary completion
2008-02-01
Completion
2008-02-01
First posted
2007-03-12
Last updated
2013-05-30

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT00446420. Inclusion in this directory is not an endorsement.