Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- fentanyl and midazolam
- Conditions
- Hypothermia
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Study group 1
Midazolam and fentanyl; continuous intravenous infusions
Intervention: fentanyl and midazolam
Study group 2
Propofol and remifentanil; continuous intravenous infusion
Intervention: remifentanil and propofol
Outcomes
Primary Outcomes
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.
Time Frame: 2010