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PCAPS: Patient-Controlled Propofol Sedation in Diagnostic Colonoscopies
NCT07653867Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Jun 2028
- Countries
- 1
- Sponsor
- Karolinska Institutet
01
Overview
Phase 4, randomised, open-label trial of propofol injection (veterinary) (2 arms), sponsored by Karolinska Institutet. Primary endpoint: Patient satisfaction at 1 week. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Patient controlled propofol sedation
Patients self-administer propofol (5 mg iv, max 40 mg/min)
Nurse assisted propofol sedation
Nurse administers propofol (10 mg iv bolus)
03
Who it enrols
Patients scheduled for elective diagnostic colonoscopy in propofol sedation, ASA I-II, able to use the device and complete questionnaires. Excludes ASA >= III, pregnant/breastfeeding women, and those with cognitive impairment or severe psychiatric illness.
04
Endpoints
Primary
Patient satisfaction
Secondary
Total propofol dose
Recovery time
Procedure duration
Adverse events
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