Status:
COMPLETED
Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Conditions:
Hypothermia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubat...
Eligibility Criteria
Inclusion
- Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
- Patients must be 18 years or older
- Inclusion must be approved by the attending physician
Exclusion
- Pregnant women
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00667043
Start Date
April 1 2008
End Date
June 1 2010
Last Update
December 29 2023
Active Locations (2)
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1
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4068
2
St. Olavs Hospital
Trondheim, Sør-Trøndelag, Norway, 7006