Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography (PER-projekt)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endoscopic Retrograde Cholangiopancreatography |
Drug: Propofol sedation by nurse anaesthestist Drug: Patient-controlled propofol sedation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography |
- treatability [ Time Frame: one day (per-procedural) ] [ Designated as safety issue: No ]Registration of number of failures (where procedure is interrupted as a result of inadequate sedation). Comparison data between propofol PCS and nurse anaesthetists sedation using propofol and control group (midazolam).
- safety [ Time Frame: one and a half year ] [ Designated as safety issue: Yes ]Vital signs and interventions of nurse anaesthetists. Data on heart rate, blood pressure, peripheral oxygen saturatuion, respiratory rate, delivery of oxygen, airway obstruction assessment, airway manipulation.
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Propofol sedation by nurse anaesthetist
Nurse anaesthetists managed infusion of propofol 10 mg/ml at doses of 0.2 - 0.8 ml/kg during ERCP. The target of moderate sedation was achieved within 5 minutes from start of the sedation.
|
Drug: Propofol sedation by nurse anaesthestist
Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation. Patient-controlled sedation: self-administration of propofol boluses of 5 mg with zero lock-out time. Administration time for the pump was 12 sec, equivalent to maximum delivery of 25 mg of propofol per minute. Propofol sedation by nurse anaesthetists: |
|
Active Comparator: Patient-controlled propofol sedation
Self-administration of propofol via patient-controlled sedation pump (CME...). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute. Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness. |
Drug: Patient-controlled propofol sedation
Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation. Self-administration of propofol via patient-controlled sedation pump (CME T-34L PCA). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute. Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness. |
|
No Intervention: Midazolam sedation by the ERCP-team
Midazolam doses for sedation during ERCP. Initial dose of 2-3 mg and after ERCP start, 1-2 mg as additional doses. Maximum total dose 6-8 mg. ERCP performing doctor is responsible for dose ordination.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Need for ERCP
- Able to speak and read swedish
Exclusion Criteria:
- Allergy to propofol
- Severe cardiopulmonary disease (ASA IV)
- Confusion or dementia
Contacts and Locations| Contact: Folke Sjöberg, Professor | +46 (0)70-5571820 | folke.sjoberg@liu.se |
| Sweden | |
| Linköping University Hospital | Recruiting |
| Linköping, Sweden, 581 85 | |
| Contact: Folke Sjöberg, Professor +46 (0)70-5571820 folke.sjoberg@liu.se | |
| Study Chair: | Folke Sjöberg, Professor | Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden |
More Information
No publications provided
| Responsible Party: | Lena Nilsson, MD, PhP, senior consultant, University Hospital, Linkoeping |
| ClinicalTrials.gov Identifier: | NCT01505218 History of Changes |
| Other Study ID Numbers: | PER 2010/232-31 |
| Study First Received: | December 13, 2011 |
| Last Updated: | January 5, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital, Linkoeping:
|
Sedation propofol patient-controlled safety |
Additional relevant MeSH terms:
|
Propofol Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 19, 2013