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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
  Purpose

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.


Condition Intervention
Endoscopic Retrograde Cholangiopancreatography
Drug: Propofol sedation by nurse anaesthestist
Drug: Patient-controlled propofol sedation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Need for ERCP
  • Able to speak and read swedish

Exclusion Criteria:

  • Allergy to propofol
  • Severe cardiopulmonary disease (ASA IV)
  • Confusion or dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505218

Contacts
Contact: Folke Sjöberg, Professor +46 (0)70-5571820 folke.sjoberg@liu.se

Locations
Sweden
Linköping University Hospital Recruiting
Linköping, Sweden, 581 85
Contact: Folke Sjöberg, Professor    +46 (0)70-5571820    folke.sjoberg@liu.se   
Sponsors and Collaborators
Lena Nilsson
Investigators
Study Chair: Folke Sjöberg, Professor Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden
  More Information

No publications provided

Responsible Party: Lena Nilsson, MD, PhP, senior consultant, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01505218     History of Changes
Other Study ID Numbers: PER 2010/232-31
Study First Received: December 13, 2011
Last Updated: January 5, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Sedation
propofol
patient-controlled
safety

Additional relevant MeSH terms:
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014