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

Melbourne Health

Status and phase: Completed; Phase 4

Conditions: Cognitive Impairment

Treatments: Drug: Propofol, midazolam, fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00446420

2006.228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

1

Active Comparator group

Description:

These patients will only receive intravenous propofol which will be titrated to an OAA/S score of 3. They will not receive fentanyl, midazolam or any other drugs

Treatment:

Drug: Propofol, midazolam, fentanyl

2

Active Comparator group

Description:

These patients will receive propofol plus midazolam and/or fentanyl. Midazolam and fentanyl will be given in fixed doses first and propofol will be titrated to effect. All drugs will be given intravenously.

Treatment:

Drug: Propofol, midazolam, fentanyl