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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Drug: Propofol, midazolam, fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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 | Drug: Propofol, midazolam, fentanyl<br>* All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy<br>* Other names: Versed;|
| Active Comparator: 2<br>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. | Drug: Propofol, midazolam, fentanyl<br>* All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy<br>* Other names: Versed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive impairment at hospital discharge after elective outpatient colonoscopy |  | Before discharge from daycare facility | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care |  | Before discharge from daycare facility |