Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

Conditions
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Hypothermia

Intervention / Treatment
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* Drug: remifentanil and propofol
* Drug: fentanyl and midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group 1<br>Midazolam and fentanyl; continuous intravenous infusions | Drug: fentanyl and midazolam<br>* 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.<br>|
| Active Comparator: Study group 2<br>Propofol and remifentanil; continuous intravenous infusion | Drug: remifentanil and propofol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic hypothermia, cardiac arrest, sedation, remifentanil, propofol, fentanyl, midazolam