Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

NCT01505218 | Completed

• 1 other identifier: PER 2010/232-31
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

Sedation; propofol; patient-controlled; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vital signs

  one and a half year

Study Arms (3)

Propofol sedation by nurse anaesthetist

ACTIVE COMPARATOR

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

Patient-controlled propofol sedation

ACTIVE COMPARATOR

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

Midazolam sedation by the ERCP-team

NO INTERVENTION

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.

Interventions

Propofol sedation by nurse anaesthestist DRUG

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:

Propofol sedation by nurse anaesthetist

Patient-controlled propofol sedation DRUG

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.

Patient-controlled propofol sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need for ERCP
• Able to speak and read swedish

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Linköping University Hospital

Linköping, 581 85, Sweden

Location

Study Officials

• Folke Sjöberg, Professor

  Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhP, senior consultant

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: January 6, 2012
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 9, 2020

Record last verified: 2015-12

Locations

SE (1)