Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
NCT ID: NCT00667043
Last Updated: 2023-12-29
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
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2008-04-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Study group 1
Midazolam and fentanyl; continuous intravenous infusions
fentanyl and midazolam
Patients will receive: midazolam; continuous intravenous infusion, concentration 5 mg/ml, 2-10 mg/hour and fentanyl; continuous intravenous infusion, concentration 0,050 mg/ml, 0.025-0.5 mg/hour. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
Study group 2
Propofol and remifentanil; continuous intravenous infusion
remifentanil and propofol
Patients will receive: propofol, continuous intravenous infusion, concentration 10 mg/ml, 1-4 mg/kg/hour and remifentanil; continuous intravenous infusion 0,050 mg/ml, 0.1-0.3 microgram/kg/min. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
Interventions
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remifentanil and propofol
Patients will receive: propofol, continuous intravenous infusion, concentration 10 mg/ml, 1-4 mg/kg/hour and remifentanil; continuous intravenous infusion 0,050 mg/ml, 0.1-0.3 microgram/kg/min. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
fentanyl and midazolam
Patients will receive: midazolam; continuous intravenous infusion, concentration 5 mg/ml, 2-10 mg/hour and fentanyl; continuous intravenous infusion, concentration 0,050 mg/ml, 0.025-0.5 mg/hour. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
Eligibility Criteria
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Inclusion Criteria
* Patients must be 18 years or older
* Inclusion must be approved by the attending physician
Exclusion Criteria
* Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
* Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
* History of drug allergies, or contraindications for the study drugs
* Patients using a scheduled dose of any of the study drugs.
* Patients with a known substance abuse of opioids or benzodiazepines
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Pål Klepstad, MD, PhD
Role: STUDY_DIRECTOR
National Taiwan Normal University
Locations
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Stavanger University Hospital
Stavanger, Rogaland, Norway
St. Olavs Hospital
Trondheim, Sør-Trøndelag, Norway
Countries
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References
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Bjelland TW, Dale O, Kaisen K, Haugen BO, Lydersen S, Strand K, Klepstad P. Propofol and remifentanil versus midazolam and fentanyl for sedation during therapeutic hypothermia after cardiac arrest: a randomised trial. Intensive Care Med. 2012 Jun;38(6):959-67. doi: 10.1007/s00134-012-2540-1. Epub 2012 Apr 12.
Other Identifiers
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OPI 07 001
Identifier Type: -
Identifier Source: org_study_id