NCT01505218

Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endoscopic Retrograde Cholangiopancreatography

Interventions

Type	Name	Description
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:
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-01-06
• Last updated: 2020-11-09

Locations

1 site across 1 country: Sweden