elective ERCP(endoscopic retrograde cholangiopancreatography) patients MedDRA version: 12.0 Level: HLGT Classification code 10019654 Term: Hepatic and hepatobiliary disorders MedDRA version: 12.0 Level: HLT Classification code 10019808 Term: Hepatobiliary imaging procedures MedDRA version: 12.0 Level: HLT Classification code 10027692 Term: Pancreatic disorders NEC
Conditions
Interventions
Trade Name: PROPOFOL-LIPURO 10 mg/ml (1 %)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Helsinki University Central hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -elective ERCP-patients of age 18-75 and ASA class 1-3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -allergy to propofol or alfentanyl -pregnancy -inability to cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to compare Patient-controlled sedation with propofol to Target-controlled infusion of propofol in elective ERCP-patients;Secondary Objective: recovery time,propofol consumption,adverse effects,sedation degree,patient`s and endoscopist`s satisfaction;Primary end point(s): -sedation degree -patients end endoscopists satisfaction -propofol consumption -vital signs | — |
Countries
Finland
Outcome results
None listed