Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Sedation
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- patient's and endoscopist´s satisfaction,
- Status
- Completed
- Last Updated
- 5 years ago
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 .
Investigators
Maxim Mazanikov
MD
Helsinki University Central Hospital
Eligibility Criteria
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