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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014862-25 | EudraCT Number |
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In this pilot prospective non-commercial clinical trial the investigators will study the use of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a placebo-controlled and randomized manner in patients with drug addiction during Endoscopic Retrograde Cholangiopancreatography (ERCP). Dexmedetomidine is a sedative medication used mostly in intensive care units,and is marketed under the brand name Precedex. Dexmedetomidine has sedative, analgesic, sympatholytic, and anxiolytic properties. It produces sedation without causing significant respiratory depression. Recent research has suggested dexmedetomidine to be effective in treatment of alcohol withdrawal signs. In previous studies dexmedetomidine was insufficient as an only sedative agent in ERCP and colonoscopy, but it has not been assessed for sedation in patients with chronic pancreatitis. The main objective of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption and facilitate the performance of ERCP in patients with chronic pancreatitis due to drug addiction.Secondary objectives of the trial are the stability of vital signs and safety, patients´ satisfaction plus recovery time from sedation.
50 elective ERCP patients with chronic pancreatitis after written informed consent and randomisation will be recruited to the study. Exclusion criteria are:allergy to propofol, opioid or dexmedetomidine, ASA class greater than 3. All the patients will receive patient-controlled propofol sedation. In dexmedetomidine group dexmedetomidine infusion will be started before sedation beginning and in placebo group placebo-solution (NaCl0,9%) will be administered in the similar manner.Standard monitoring for vital signs will be applied,also sedation degrees will be evaluated with sedation scores. At the end of procedure total amount of propofol and opioid will be calculated,patients and endoscopists satisfaction and the difficulty of ERCP will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Active Comparator | sedative medicine |
|
| sodium chloride 0,9% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precedex | Drug | mkg/ml,continuous infusion at rate 0.7 µg/kg/h |
|
| Measure | Description | Time Frame |
|---|---|---|
| sedation degree | 1 day | |
| propofol consumption | 1 day | |
| endoscopist´s and patient´s satisfaction | 1 day | |
| vital signs:blood pressure, oxygen saturation, heart rate, breathing rate | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maxim Mazanikov, MD | Helsinki University Central Hospital,Department of Anaesthesiology | Principal Investigator |
| Marianne Udd, MD,PhD | Helsinki University Central Hospital,Department of Surgery | Principal Investigator |
| Outi Lindström, MD | Helsinki University Central Hospital,Department of Surgery | Principal Investigator |
| Leena Kylänpää, Docent | Helsinki University Central Hospital,Department of Surgery | Principal Investigator |
| Jorma Halttunen, Docent | Helsinki University Central Hospital,Department of Surgery | Principal Investigator |
| Martti Färkkilä, Professor | Helsinki University Central Hospital,Department of Gastroenterology | Principal Investigator |
| Reino Pöyhiä, Docent | Helsinki University Central Hospital,Department of Anaesthesiology | Study Director |
| Harri Mustonen, PhD | Department of Gastrointestinal and General Surgery, Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit | Helsinki | Uusimaa | 00029 | Finland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 18, 2020 | |
| Reset | Jan 13, 2021 | |
| Release | Apr 30, 2021 | |
| Reset | May 24, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 18, 2020 | Jan 13, 2021 | |||
| Apr 30, 2021 |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| sodium chlorid 0,9% | Drug | continuous intravenous infusion |
|
|
| May 24, 2021 |