Anaesthesia
Conditions
Keywords
AMBULATORY CARE, AWARENESS AND RECALL, Propofol, Patient Safety and Satisfaction, Colonoscopy, Elective outpatient colonoscopy, Procedural sedation
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.
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.
Interventions
OTHERSedation 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).
Sponsors
Melbourne Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recall of procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Complications | 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 | 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 | 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 | 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. |
Countries
Australia
Outcome results
None listed