Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-02 @ 6:41 AM
Study NCT ID:
NCT00446420
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2007-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Sponsor:
Melbourne Health
Organization:
Study Overview
Official Title:
Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: