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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01079312 |
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Date of registration:
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01/03/2010 |
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Primary sponsor: |
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Public title:
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Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)
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Scientific title:
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Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01079312 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Finland
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Contacts
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Name:
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Maxim Mazanikov, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Anaesthesiology |
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Name:
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Reino Pöyhiä, Docent |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Anaesthesiology |
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Name:
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Martti Färkilä, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Gasroenterology |
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Name:
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Jorma Halttunen, Docent |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Surgery |
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Name:
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Leena Kylänpää, Docent |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Surgery |
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Name:
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Marianne Udd, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Surgery |
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Name:
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Outi Lindström, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Surgery |
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Name:
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Pekka Aho, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital,Department of Vascular Surgery |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- elective ERCP-patients
Exclusion Criteria:
- allergy to propofol or opioid;
- ASA-class (American Society of Anaesthesiology) greater than 3;
- inability to co-operate;
- drugs abuse.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Endoscopic Retrograde Cholangiopancreatography
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Intervention(s)
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Device: infusion pump
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Device: infusion pump for patient-controlled sedation
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Drug: fentanyl
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Drug: propofol
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Drug: remifentanil hydrochlorid
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Drug: sedative mixture
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Primary Outcome(s)
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patient´s and endoscopist´s satisfaction
[Time Frame: one day]
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propofol and opioid consumption
[Time Frame: one day]
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vital signs
[Time Frame: one day]
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Secondary Outcome(s)
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sedation level
[Time Frame: one day]
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Secondary ID(s)
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2008-007968-42
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a001c
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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