Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01457274




Registration number
NCT01457274
Ethics application status
Date submitted
22/09/2011
Date registered
21/10/2011
Date last updated
27/04/2015

Titles & IDs
Public title
"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy
Scientific title
A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery
Secondary ID [1] 0 0
2011.066
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Sedation depth

Experimental: "light" sedation - In this study the depth of sedation will be guided by the Bispectral Index monitor (BIS monitor). A BIS value of 70-80 will be targeted in the "light" sedation arm.

Active comparator: "deep" sedation - In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.


Other interventions: Sedation depth
The intervention is the depth of sedation targeted in this study.

Patients enrolled in this study will be sedated with the same medications (fentanyl bolus and propofol target controlled infusion), and at the same starting doses, in each study arm. However, the depth of sedation targeted will differ between the arms, and this depth will be guided by the BIS monitor.

It is expected that those patients randomised to "deep" sedation will require a higher dose of sedative medication to achieve their target BIS value (\<60) than those in the "light" sedation group (BIS 70-80).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recall of procedure
Timepoint [1] 0 0
1 day. Day of procedure
Secondary outcome [1] 0 0
Complications
Timepoint [1] 0 0
1 day. Day of procedure only.
Secondary outcome [2] 0 0
Speed and quality of recovery
Timepoint [2] 0 0
1 day. Day of procedure only. Measured before discharge from hospital
Secondary outcome [3] 0 0
Satisfaction
Timepoint [3] 0 0
1 day. Day of procedure only. Measured before discharge from hospital
Secondary outcome [4] 0 0
Dreaming
Timepoint [4] 0 0
1 day. Day of procedure.

Eligibility
Key inclusion criteria
* Plan for elective outpatient colonoscopy under sedation
* Able and willing to provide written informed consent for study entry and completion of all study related procedures
* American Society of Anesthesiologists' (ASA) physical status grade 1-3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Colonoscopy and gastroscopy booked as joint procedures
* Colonoscopy on emergency patients and/or inpatients
* Inadequate English comprehension (verbal and written to understand the Participant Information and Consent Form)
* Intellectual or psychiatric disability that prevents consent to and comprehension of study procedures
* Significant cognitive impairment that prevents independent conduct of activities of daily living or results in 3rd party procedural consent being obtained
* ASA physical status grade 4-5

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this trial, patients undergoing elective colonoscopy under sedation will be randomised to BIS-guided sedation targeting either "light" (bispectral index \[BIS\] 70-80) or "deep" (BIS\<60) sedation. Sedation will be achieved with a standardised regimen of target-controlled infusion of propofol and fentanyl bolus. The primary end point will be the incidence of procedure recall in each group - this will be assessed at the conclusion of the procedure. The procedural conditions, cardio-respiratory complications and recovery including cognitive function will be assessed during and immediately after the procedure. The incidence of dreaming and patient satisfaction with anaesthesia care will be recorded immediately after the procedure. The study will be complete when the patient leaves the hospital on the day of the procedure.
Trial website
https://clinicaltrials.gov/study/NCT01457274
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Megan L Allen, BMBS
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01457274