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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015564-34 | EudraCT Number |
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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).
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient-controlled sedation | Active Comparator | PCS |
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| target-controlled infusion | Active Comparator | TCI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-controlled sedation | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Reino Pöyhiä, Docent | Helsinki University Central Hospital,Department of Anaesthesiology | Study Chair |
| Harri Mustonen, PhD | Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit | Helsinki | Uusimaa | 00029 | Finland |
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| Target-controlled infusion | Device | Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol |
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