Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography
Overview
- Phase
- N/A
- Intervention
- Propofol sedation by nurse anaesthestist
- Conditions
- Endoscopic Retrograde Cholangiopancreatography
- Sponsor
- University Hospital, Linkoeping
- Enrollment
- 281
- Locations
- 1
- Primary Endpoint
- treatability
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Lena Nilsson
MD, PhP, senior consultant
University Hospital, Linkoeping
Eligibility 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
Arms & Interventions
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.
Intervention: Propofol sedation by nurse anaesthestist
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.
Intervention: Patient-controlled propofol sedation
Outcomes
Primary Outcomes
treatability
Time Frame: one day (per-procedural)
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).
Secondary Outcomes
- Vital signs(one and a half year)