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Completed

NCT Number: NCT01457274

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

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.

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Key information

Conditions

Anaesthesia Behavior Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation depth

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    • Hypoxia
    • Airway obstruction
    • Hypotension
    • Bradycardia
    • Agitation

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Registry information

Official study title

A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2011
Registry last updated
Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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