Clinical trial NCT01072435: Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: ERCP
patient-controlled sedation
target-controlled infusion
propofol
Sedation with propofol for ERCP
Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: sedation degrees
timeFrame: One day
measure: patient's and endoscopist´s satisfaction,
timeFrame: One day
measure: propofol consumption
timeFrame: One day
measure: vital signs:oxygen saturation,blood pressure,heart rate,breathing rate
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit
state: Uusimaa
Study officials:
affiliation: Helsiki University Central Hospital,Department of Anaesthesiology
name: Maxim Mazanikov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Marianne Udd, MD.,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Leena Kylänpää, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Outi Lindström, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Jorma Halttunen, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastroenterology
name: Martti Färkilä, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Anaesthesiology
name: Reino Pöyhiä, Docent
role: STUDY_CHAIR
affiliation: Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland
name: Harri Mustonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: