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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Melbourne Health
Sponsor:
Information provided by (Responsible Party):
Associate Professor Kate Leslie, Melbourne Health
ClinicalTrials.gov Identifier:
NCT01457274
First received: September 22, 2011
Last updated: June 2, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Anaesthesia
Other: Sedation depth

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Recall of procedure [ Time Frame: 1 day. Day of procedure ] [ Designated as safety issue: Yes ]
    Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation


Secondary Outcome Measures:
  • Complications [ Time Frame: 1 day. Day of procedure only. ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: "deep" sedation
In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457274

Locations
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Megan Allen    +61-3-93427000      
Contact: Kate Leslie    +61-3-93427000      
Principal Investigator: Megan Allen         
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Megan L Allen, BMBS Melbourne Health
Principal Investigator: Kate Leslie, MBBS Melbourne Health
  More Information

No publications provided

Responsible Party: Associate Professor Kate Leslie, Head of Reaseach and Staff anaesthetist, The Royal Melbourne Hospital, Melbourne Health
ClinicalTrials.gov Identifier: NCT01457274     History of Changes
Other Study ID Numbers: 2011.066
Study First Received: September 22, 2011
Last Updated: June 2, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Melbourne Health:
AMBULATORY CARE
AWARENESS AND RECALL
Propofol
Patient Safety and Satisfaction
Colonoscopy
Elective outpatient colonoscopy
Procedural sedation

ClinicalTrials.gov processed this record on October 21, 2014