Cognitive Impairment
Conditions
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.
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.
Interventions
DRUGPropofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Sponsors
Melbourne Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation
Exclusion criteria
* No cognitive impairment * Adequate English language comprehension * Not combined with other procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive impairment at hospital discharge after elective outpatient colonoscopy | Before discharge from daycare facility |
Secondary
| Measure | Time frame |
|---|---|
| Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care | Before discharge from daycare facility |
Countries
Australia
Outcome results
None listed