A randomised controlled trial of “light” versus “deep” sedation for elective outpatient colonoscopy: recall, procedural conditions and recovery

In patients booked for elective, outpatient colonoscopy under sedation are those who are lightly sedated, compared to those deeply sedated, equally likely to have recall of the procedure.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000320954

Enrollment

200

Registered

2011-03-25

Start date

2011-10-06

Completion date

2013-10-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this trial, patients undergoing elective colonoscopy under sedation will be randomised to BIS-guided sedation targeting either “light” or “deep” 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. The procedural conditions, cardio-respiratory complications and recovery including cognitive function will be assessed. The patient satisfaction with anaesthesia care will be recorded.

Interventions

Sedation will be with an intravenous infusion of propofol (a IV anaesthetic agent) using TCI effect site steered dosing with a start point of 1.5mcg/ml. This will be titrated by the anaesthetist to achieve the target BIS with no maximum dose. A bolus dose of fentanyl (an opioid) of 0.7mcg/kg to a maximum of 100mcg will be given for those under 70 years, and for those over 70 years this will be 0.5mcg/kg to a maximum of 75mcg. The sedation will continue for the duration of the colonoscopy (usual duration 20-30 mins). The bispectral index (BIS) is a modified EEG signal which is a validated measure for the depth of anaesthesia which generates a number from 0 (no cortical activity) to 100 (awake). Measurement is made by the placement of a measurement strip on the patient's forehead. In this study the intervention is "light sedation" in which the BIS target will be 70-80. The propofol infusion will be increased or decreased to remain in this range.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Booked for elective outpatient colonoscopy under sedation ASA physical status grade 1-3 Adequate english language comprehension to complete study procedures Cognitive function sufficient to provide own consent for the procedure

Exclusion criteria

Booked for combined colonoscopy and gastroscopy emergency inpatient procedures significant cardio-respiratory dysfunction (ASA4-5)

Outcome results