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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01072435

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sedation	Device: Patient-controlled sedation Device: Target-controlled infusion	Phase 4

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 .

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: patient-controlled sedation PCS	Device: Patient-controlled sedation 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. Other Names: Arcomed/Syramed AG infusion pump designed for self administration of medicines
Active Comparator: target-controlled infusion TCI	Device: Target-controlled infusion Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol Other Names: Arcomed/Syramed AG target-controlled infusion device.

Arm

Intervention/Treatment

Active Comparator: patient-controlled sedation

PCS

Device: Patient-controlled sedation

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.

Other Names:

Arcomed/Syramed AG infusion pump designed for self administration of medicines

Active Comparator: target-controlled infusion

TCI

Device: Target-controlled infusion

Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol

Other Names:

Arcomed/Syramed AG target-controlled infusion device.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

elective ERCP patients

Exclusion Criteria:

allergy to propofol or opioid;
inability to cooperate;
ASA(American Society of Anaesthesiology)class greater than 3

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit	Helsinki	Uusimaa	Finland	00029

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Principal Investigator: Maxim Mazanikov, MD, Helsiki University Central Hospital,Department of Anaesthesiology
Principal Investigator: Marianne Udd, MD.,PhD, Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Leena Kylänpää, Docent, Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Outi Lindström, MD, Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Jorma Halttunen, Docent, Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Martti Färkilä, Professor, Helsinki University Central Hospital,Department of Gastroenterology
Study Chair: Reino Pöyhiä, Docent, Helsinki University Central Hospital,Department of Anaesthesiology
Principal Investigator: Harri Mustonen, PhD, Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland