Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography (PER-projekt)

University Hospital, Linkoeping

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Drug: Patient-controlled propofol sedation; Drug: Propofol sedation by nurse anaesthestist

Study type: Interventional

Funder types: Other

Identifiers

NCT01505218

PER 2010/232-31

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need for ERCP
• Able to speak and read swedish

Exclusion criteria

• Allergy to propofol
• Severe cardiopulmonary disease (ASA IV)
• Confusion or dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 3 patient groups

Propofol sedation by nurse anaesthetist

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol sedation by nurse anaesthestist

Patient-controlled propofol sedation

Active Comparator group

Description:

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.

Treatment:

Drug: Patient-controlled propofol sedation

Midazolam sedation by the ERCP-team

No Intervention group

Description:

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.