ERCP(Endoscopic retrograde cholangiopancreatography) MedDRA version: 12.1 Level: LLT Classification code 10049192 Term: Pancreatic fistula MedDRA version: 12.1 Level: LLT Classification code 10052108 Term: Pancreatic duct stone MedDRA version: 12.1 Level: HLT Classification code 10033634 Term: Pancreatic therapeutic procedures MedDRA version: 12.1 Level: LLT Classification code 10033615 Term: Pancreatic cyst MedDRA version: 12.1 Level: LLT Classification code 10033616 Term: Pancreatic disor
Conditions
Interventions
Trade Name: Precedex
Product Name: Precedex
Pharmaceutical Form:
CAS Number: 145108-58-3
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Concentration unit: µg/ml microgram(s)/millilitre
Concen
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -elective ERCP; -alcohol dependence 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: -inability to cooperate; -allergy to propofol or dexmedetomidine ; -ASA class greater then 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: main objective of the trial is to compare Dexmedetomidine and placebo in patient-controlled sedation during ERCP.;Secondary Objective: hemodynamic changes,sedation degree,propofol consumption,patient´s and endoscopists satisfaction;Primary end point(s): -Blood pressure; -oxygen saturation; -sedation degree; -propofol consumption | — |
Countries
Finland
Outcome results
None listed