Hypothermia
Conditions
Keywords
therapeutic hypothermia, cardiac arrest, sedation, remifentanil, propofol, fentanyl, midazolam
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 extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.
Interventions
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.
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.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam. | 2010 |
Countries
Norway
Outcome results
None listed