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

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Propofol, midazolam, fentanyl
Sponsored by
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm 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

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.

Outcomes

Primary Outcome Measures

Cognitive impairment at hospital discharge after elective outpatient colonoscopy

Secondary Outcome Measures

Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care

Full Information

First Posted
March 8, 2007
Last Updated
May 28, 2013
Sponsor
Melbourne Health
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1. Study Identification

Unique Protocol Identification Number
NCT00446420
Brief Title
Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Official Title
Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm 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
Arm Title
2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propofol, midazolam, fentanyl
Other Intervention Name(s)
Diprivan, Sublimase, Versed
Intervention Description
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Primary Outcome Measure Information:
Title
Cognitive impairment at hospital discharge after elective outpatient colonoscopy
Time Frame
Before discharge from daycare facility
Secondary Outcome Measure Information:
Title
Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care
Time Frame
Before discharge from daycare facility

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Leslie, MD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
19617584
Citation
Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17.
Results Reference
derived

Learn more about this trial

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

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