Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

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 .

Official Title
-----------------
Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Device: Patient-controlled sedation
* Device: Target-controlled infusion


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patient-controlled sedation<br>PCS | Device: Patient-controlled sedation<br>* Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.<br>* Other names: Arcomed/Syramed AG infusion pump designed for self administration of medicines;|
| Active Comparator: target-controlled infusion<br>TCI | Device: Target-controlled infusion<br>* Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol<br>* Other names: Arcomed/Syramed AG target-controlled infusion device.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation degrees |  | One day | 
| patient's and endoscopist´s satisfaction, |  | One day | 
| propofol consumption |  | One day | 
| vital signs:oxygen saturation,blood pressure,heart rate,breathing rate |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, patient-controlled sedation, target-controlled infusion, propofol, Sedation with propofol for ERCP, Endoscopic Retrograde Cholangiopancreatography