ERCP (Endoscopic Retrograde Cholangiopancreatography) MedDRA version: 9.1 Level: LLT Classification code 10004676 Term: Biliary tract disease MedDRA version: 9.1 Level: LLT Classification code 10004678 Term: Biliary tract endoscopy MedDRA version: 9.1 Level: LLT Classification code 10033616 Term: Pancreatic disorder MedDRA version: 9.1 Level: LLT Classification code 10053331 Term: Pancreatic sphincter operation MedDRA version: 9.1 Level: LLT Classification code 10064858 Term: Pancreatic duc
Conditions
Interventions
Trade Name: PROPOFOL-LIPURO 10 mg/ml (1 %)
Product Name: PROPOFOL-LIPURO 10 mg/ml
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Propofol
Trade Name: ULTIVA® 1 mg
Product Name: ULT
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Elective ERCP patients 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: under-age, propofol or/and remifentanyl allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: procedure performance and complications;Secondary Objective: level of sedation, stability of patient’s vital functions, need of supplemental sedation, recovery time.;Primary end point(s): vital functions:oxygen saturation, end-tidal CO2-concentration measurement, non-invasive automatic blood pressure,continuous electrocardiography;difficulty and the technical performance of the procedure;a patient’s opinion about method;procedural and recovery times;propofol concentrations | — |
Countries
Finland
Outcome results
None listed