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"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy

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ClinicalTrials.gov Identifier: NCT01457274
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
Associate Professor Kate Leslie, Melbourne Health

September 22, 2011
October 21, 2011
April 27, 2015
September 2011
December 2014   (Final data collection date for primary outcome measure)
Recall of procedure [ Time Frame: 1 day. Day of procedure ]
Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation
Same as current
Complete list of historical versions of study NCT01457274 on ClinicalTrials.gov Archive Site
  • Complications [ Time Frame: 1 day. Day of procedure only. ]
    The treating anaesthetist will record if any of the following complications occur during the sedation for colonoscopy.
    1. Hypoxia
    2. Airway obstruction
    3. Hypotension
    4. Bradycardia
    5. Agitation
  • Speed and quality of recovery [ Time Frame: 1 day. Day of procedure only. Measured before discharge from hospital ]
    Time from starting sedation until opening eyes in the post anaesthesia care unit, and time until readiness for hospital discharge will be recorded. Cognitive function at hospital discharge, compared to pre-procedure function, will be assessed by the CogState(TM) test battery.
  • Satisfaction [ Time Frame: 1 day. Day of procedure only. Measured before discharge from hospital ]
    Proceduralist and anaesthetist satisfaction with the sedation will be recorded at the end of the procedure. Patient satisfaction with their anaesthesia care will be assessed at the time they are ready for hospital discharge.
  • Dreaming [ Time Frame: 1 day. Day of procedure. ]
    Upon rousing in the post anaesthesia care unit patients will be asked the modified Brice questionnaire ("What is the last thing you remember before you went to sleep?", "What is the first thing you remember when you woke up?", "Did you remember anything in between?", and "Did you have any dreams?"). Dreaming will be assessed by the response to quesion 4.
Same as current
Not Provided
Not Provided
 
"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy
A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery
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.
Controversy exists about the need for deep sedation or light sedation during elective colonoscopy. Deep sedation ensures amnesia for the procedure and may ensure better operating conditions, but may result in cardiorespiratory side effects and prolonged recovery. Differences exist between countries regarding the prevailing depth of sedation with deeper sedation in general being administered in Australia than the United States. This study aims to explore that controversy.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Anaesthesia
Other: 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).

Other Names:
  • BIS monitor
  • Bispectral index
  • Aspect medical
  • 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.
    Intervention: Other: Sedation depth
  • Active Comparator: "deep" sedation
    In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.
    Intervention: Other: Sedation depth
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Same as current
December 2014
December 2014   (Final data collection date for primary outcome measure)

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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01457274
2011.066
No
Not Provided
Not Provided
Associate Professor Kate Leslie, Melbourne Health
Melbourne Health
Not Provided
Principal Investigator: Megan L Allen, BMBS Melbourne Health
Principal Investigator: Kate Leslie, MBBS Melbourne Health
Melbourne Health
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP