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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446420
• Other study ID #: 2006.228
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2007
• Last updated: May 28, 2013
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2013
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment

Intervention

Drug:
• Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive impairment at hospital discharge after elective outpatient colonoscopy		Before discharge from daycare facility	No
Secondary	Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care		Before discharge from daycare facility	No