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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University Hospital, Linkoeping.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01505218
First received: December 13, 2011
Last updated: January 5, 2012
Last verified: January 2012

December 13, 2011
January 5, 2012
October 2010
December 2012   (final data collection date for primary outcome measure)
treatability [ Time Frame: one day (per-procedural) ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01505218 on ClinicalTrials.gov Archive Site
safety [ Time Frame: one and a half year ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endoscopic Retrograde Cholangiopancreatography
  • 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.

  • 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.
    Intervention: Drug: Propofol sedation by nurse anaesthestist
  • 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.

    Intervention: Drug: Patient-controlled propofol sedation
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Need for ERCP
  • Able to speak and read swedish

Exclusion Criteria:

  • Allergy to propofol
  • Severe cardiopulmonary disease (ASA IV)
  • Confusion or dementia
Both
18 Years and older
No
Contact: Folke Sjöberg, Professor +46 (0)70-5571820 folke.sjoberg@liu.se
Sweden
 
NCT01505218
PER 2010/232-31
No
Lena Nilsson, University Hospital, Linkoeping
Lena Nilsson
Not Provided
Study Chair: Folke Sjöberg, Professor Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden
University Hospital, Linkoeping
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP