Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography
Information source: University Hospital, Linkoeping
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endoscopic Retrograde Cholangiopancreatography
Intervention: Propofol sedation by nurse anaesthestist (Drug); Patient-controlled propofol sedation (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Lena Nilsson Official(s) and/or principal investigator(s): Folke Sjöberg, Professor, Study Chair, Affiliation: Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden
Overall contact: Folke Sjöberg, Professor, Phone: +46 (0)70-5571820, Email: folke.sjoberg@liu.se
Summary
Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography
(ERCP). Combination of sedatives and opioids is associated with increased
morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system
(patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative
studies with PCS for ERCP are few. Therefore, the main objective of this randomized
controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists
during ERCP.
Clinical Details
Official title: Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: treatability
Secondary outcome: safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Need for ERCP
- Able to speak and read swedish
Exclusion Criteria:
- Allergy to propofol
- Severe cardiopulmonary disease (ASA IV)
- Confusion or dementia
Locations and Contacts
Folke Sjöberg, Professor, Phone: +46 (0)70-5571820, Email: folke.sjoberg@liu.se
Linköping University Hospital, Linköping 581 85, Sweden; Recruiting Folke Sjöberg, Professor, Phone: +46 (0)70-5571820, Email: folke.sjoberg@liu.se
Additional Information
Starting date: October 2010
Last updated: January 5, 2012
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