Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography
NCT ID: NCT01505218
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
281 participants
INTERVENTIONAL
2010-10-31
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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:
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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:
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to speak and read swedish
Exclusion Criteria
* Severe cardiopulmonary disease (ASA IV)
* Confusion or dementia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Linkoeping
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lena Nilsson
MD, PhP, senior consultant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Folke Sjöberg, Professor
Role: STUDY_CHAIR
Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linköping University Hospital
Linköping, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PER 2010/232-31
Identifier Type: -
Identifier Source: org_study_id