Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Drug: Propofol sedation by nurse anaesthestist; Drug: Patient-controlled propofol sedation

• Registration Number: NCT01505218
• Lead Sponsor: University Hospital, Linkoeping

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-12
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

• Need for ERCP
• Able to speak and read swedish

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol sedation by nurse anaesthetist	Propofol sedation by nurse anaesthestist	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.
Patient-controlled propofol sedation	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.

Primary Outcome Measures

Name	Time	Method
treatability	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 Outcome Measures

Name	Time	Method
Vital signs	one and a half year	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.

Trial Locations

Locations (1)

Linköping University Hospital; 🇸🇪 Linköping, Sweden