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

Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Drug: Propofol sedation by nurse anaesthestist; Drug: Patient-controlled propofol sedation

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • Linköping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatability	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).	one day (per-procedural)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital signs	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.	one and a half year

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Study Chair: Folke Sjöberg, Professor, Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: safety; Sedation; propofol; patient-controlled
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: PER 2010/232-31