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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007968-42 | EudraCT Number |
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Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.
80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol infusion | Active Comparator | Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml |
|
| Patient-controlled sedation | Active Comparator | self-administration of propofol and remifentanil mixture during ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infusion pump | Device | anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level |
|
| Measure | Description | Time Frame |
|---|---|---|
| propofol and opioid consumption | total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure | one day |
| vital signs | heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration | one day |
| patient´s and endoscopist´s satisfaction | Likert scale 1-7 | one day |
| Measure | Description | Time Frame |
|---|---|---|
| sedation level | sedation level assested with Ramsay,Gillham,OAA/S sedation scores | one 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 |
| Pekka Aho, MD, PhD | Helsinki University Central Hospital,Department of Vascular Surgery | Principal Investigator |
| Jorma Halttunen, Docent | Helsinki University Central Hospital,Department of Surgery | Principal Investigator |
| Martti Färkilä, Professor | Helsinki University Central Hospital,Department of Gasroenterology | Principal Investigator |
| Reino Pöyhiä, Docent | Helsinki University Central Hospital,Department of Anaesthesiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit | Helsinki | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21295639 | Result | Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005. |
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Due to Finnish legal restriction patient data can not be accessed by others but the researches
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 21, 2021 | |
| Reset | Jun 15, 2021 |
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|
| infusion pump for patient-controlled sedation | Device | self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump. |
|
|
| propofol | Drug | Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture. |
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| fentanyl | Drug | Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated. |
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| sedative mixture | Drug | Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml) |
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| remifentanil hydrochlorid | Drug | Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 21, 2021 | Jun 15, 2021 |
| ID | Term |
|---|---|
| D007260 | Infusion Pumps |
| D015742 | Propofol |
| D005283 | Fentanyl |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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