Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000503527
Ethics application status
Approved
Date submitted
27/11/2006
Date registered
5/12/2006
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of propofol or propofol plus midazolam and/or fentanyl on cognitive impairment following colonoscopy
Scientific title
The effect of propofol or propofol plus midazolam and/or fentanyl on cognitive impairment following colonoscopy
Secondary ID [1] 288008 0
None
Secondary ID [2] 288009 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing colonoscopy 1481 0
Condition category
Condition code
Other 1575 1575 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2. Sedation individually titrated for patient requirement for the duration of colonoscopy (10-60 minutes) with variable dose intravenous propofol (50-400 mg) plus variable dose intravenous midazolam (0.5-5 mg) and/or variable dose intravenous fentanyl (10-100 mcg)
Intervention code [1] 1471 0
Prevention
Comparator / control treatment
1. Sedation individually titrated for patient requirement for the duration of colonoscopy (10-60 minutes) with a variable dose intravenous propofol (50-400 mg)
Control group
Active

Outcomes
Primary outcome [1] 2178 0
Cognitive impairment
Timepoint [1] 2178 0
At discharge from colonoscopy suite
Secondary outcome [1] 3795 0
1. Depth of sedation every 5 min during sedation
Timepoint [1] 3795 0
Every 5 min while patients are sedated during colonoscopy.
Secondary outcome [2] 3796 0
2. Endoscopist satisfaction with intraoperative conditions
Timepoint [2] 3796 0
Measured at the end of colonoscopy
Secondary outcome [3] 3797 0
3. Complications
Timepoint [3] 3797 0
Recorded at the end of colonoscopy
Secondary outcome [4] 3798 0
4. Dreaming during sedation
Timepoint [4] 3798 0
Recorded on emergence from sedation

Eligibility
Key inclusion criteria
Patients who present for elective outpatient colonoscopy, not combined with other procedures and following full bowel preparation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cognitive deficits and without adequate English language comprehension.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed in opaque envelopes until after patient consent has been obtained
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (ie. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, endoscopists, post-operative observers and data analysts will be blind to group allocation.
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
6/12/2006
Date of last participant enrolment
Anticipated
Actual
22/02/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1719 0
Hospital
Name [1] 1719 0
Royal Melbourne Hospital
Country [1] 1719 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health Research Directorate
Address
Grattan St
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 1517 0
None
Name [1] 1517 0
Nil
Address [1] 1517 0
Country [1] 1517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3177 0
Royal Melbourne Hospital
Ethics committee address [1] 3177 0
Grattan St Parkville VIC 3050
Ethics committee country [1] 3177 0
Australia
Date submitted for ethics approval [1] 3177 0
01/11/2006
Approval date [1] 3177 0
01/02/2007
Ethics approval number [1] 3177 0
2006.228

Summary
Brief summary
Patients having colonoscopy under sedation may remain sedated for some hours afterwards. This may mean that they cannot return to work inside or outside the home. Our hypothesis is that patients who receive midazolam and fentanyl, as well as propofol, will be more sedated than those who receive propofol alone, at the time of hospital discharge.
Trial website
Trial related presentations / publications
Padmanabhan U, LESLIE K, Eer A, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg 2009; 109:1448-55
Public notes

Contacts
Principal investigator
Name 27405 0
Prof Kate Leslie
Address 27405 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 27405 0
Australia
Phone 27405 0
+61-3-93427540
Fax 27405 0
Email 27405 0
[email protected]
Contact person for public queries
Name 10660 0
Prof Kate Leslie
Address 10660 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 10660 0
Australia
Phone 10660 0
+61 3 93427540
Fax 10660 0
+61 3 93428623
Email 10660 0
[email protected]
Contact person for scientific queries
Name 1588 0
Prof Kate Leslie
Address 1588 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 1588 0
Australia
Phone 1588 0
+61 3 93427540
Fax 1588 0
+61 3 93428623
Email 1588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.