AnaesthesiaNCT01457274
"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy
A study testing Sedation depth in people with Anaesthesia, run by Melbourne Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Sedation depth
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anaesthesia
- Being tested
- Sedation depth
- Keywords
- AMBULATORY CARE, AWARENESS AND RECALL, Propofol, Patient Safety and Satisfaction, Colonoscopy, Elective outpatient colonoscopy, Procedural sedation
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation depthOther
Also called BIS monitor, Bispectral index, Aspect medical
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).
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: Other: Sedation depth |
| "deep" sedation | Active comparator | In this study the "deep" sedation arm will have a BIS value of less than 60 targeted. Receives: Other: Sedation depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall of procedure
Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation
Measured: 1 day. Day of procedure
Secondary outcomes (4)
Complications
The treating anaesthetist will record if any of the following complications occur during the sedation for colonoscopy.
- Hypoxia
- Airway obstruction
- Hypotension
- Bradycardia
- Agitation
Measured: 1 day. Day of procedure only.
Speed and quality of recovery
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.
Measured: 1 day. Day of procedure only. Measured before discharge from hospital
Satisfaction
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.
Measured: 1 day. Day of procedure only. Measured before discharge from hospital
Dreaming
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.
Measured: 1 day. Day of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Kate Leslie, Melbourne Health
- Investigators
- Megan L Allen, BMBS, Principal investigator, Melbourne HealthKate Leslie, MBBS, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457274
- Sponsor's protocol ID
- 2011.066
- Status last verified
- Apr 2015
- First submitted
- 22 Sep 2011
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery
- ClinicalTrials.gov ID
- NCT01457274
- Acronym / sponsor ID
- 2011.066
- Conditions
- Anaesthesia
- Keywords
- AMBULATORY CARE, AWARENESS AND RECALL, Propofol, Patient Safety and Satisfaction, Colonoscopy, Elective outpatient colonoscopy, Procedural sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "light" sedation | Experimental | Other: Sedation depthIn 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. |
| "deep" sedation | Active comparator | Other: Sedation depthIn this study the "deep" sedation arm will have a BIS value of less than 60 targeted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation depthAlso: BIS monitor, Bispectral index, Aspect medicalThe 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 | "deep" sedation, "light" sedation |
Primary outcome
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
4 secondary outcomes
Complications
Time frame: 1 day. Day of procedure only.
Speed and quality of recovery
Time frame: 1 day. Day of procedure only. Measured before discharge from hospital
Satisfaction
Time frame: 1 day. Day of procedure only. Measured before discharge from hospital
Dreaming
Time frame: 1 day. Day of procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan L Allen, BMBS principal investigator
Melbourne Health
Kate Leslie, MBBS principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation depth in people with Anaesthesia, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall of procedure (time frame: 1 day. Day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.