Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- patient's and endoscopist´s satisfaction,
Study Overview
Brief Summary
Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).
Detailed Description
80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •elective ERCP patients
Exclusion Criteria
- •allergy to propofol or opioid;
- •inability to cooperate;
- •ASA(American Society of Anaesthesiology)class greater than 3
Outcomes
Primary Outcomes
patient's and endoscopist´s satisfaction,
Time Frame: One day
vital signs:oxygen saturation,blood pressure,heart rate,breathing rate
Time Frame: One day
sedation degrees
Time Frame: One day
propofol consumption
Time Frame: One day
Secondary Outcomes
No secondary outcomes reported
Investigators
Maxim Mazanikov
MD
Helsinki University Central Hospital