NCT01457274

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

September 22, 2011

Last Update Submit

April 23, 2015

Conditions

Anaesthesia

Keywords

AMBULATORY CAREAWARENESS AND RECALLPropofolPatient Safety and SatisfactionColonoscopyElective outpatient colonoscopyProcedural sedation

Outcome Measures

Primary Outcomes (1)

  • Recall of procedure

    Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation

    1 day. Day of procedure

Secondary Outcomes (4)

  • Complications

    1 day. Day of procedure only.

  • Speed and quality of recovery

    1 day. Day of procedure only. Measured before discharge from hospital

  • Satisfaction

    1 day. Day of procedure only. Measured before discharge from hospital

  • Dreaming

    1 day. Day of procedure.

Study Arms (2)

"light" sedation

EXPERIMENTAL

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

"deep" sedation

ACTIVE COMPARATOR

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

Other: Sedation depth

Interventions

Sedation depthOTHER

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).

Also known as: BIS monitor, Bispectral index, Aspect medical
"deep" sedation"light" sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Megan L Allen, BMBS

    Melbourne Health

    PRINCIPAL INVESTIGATOR

  • Kate Leslie, MBBS

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Reaseach and Staff anaesthetist, The Royal Melbourne Hospital

Study Record Dates

First Submitted

September 22, 2011

First Posted

October 21, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

AU(1)