Hypothermia Clinical Trial
Official title:
Requirement of Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest - a Pilot Study
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers
are in use, together with analgesia and sedation, during the cooling process in many centers
to prevent shivering. Since neuromuscular blockers are accused to be associated with various
side effects causing serious harm and/or leading to prolong ICU stay. So economical use
seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic
activity. Therefore, post hypoxic seizures might remain undetected.
Aim of this study is to investigate if a continuous application of neuromuscular blockers is
necessary to prevent shivering and thereby avoid the counter regulation to achieve the
target temperature as soon as possible in mild hypothermic therapy after cardiac arrest.
A single center (university hospital) study. Randomized, double blinded, double dummy study
design. Eligible are all adult patients after successful resuscitation due to cardiac arrest
of presumed cardiac origin.
All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed
cardiopulmonary origin will be included.
Patients <18 years, cardiac arrest >6 hours before admittance at the hospital, patients with
known or clinically apparent pregnancy, patients who reach our hospital with a body
temperature below 35°C, patients with known allergic reactions against rocuronium, patients
with a history of myasthenia gravis, patients with obvious intoxication, wards of the
state/prisoners and patients with known epileptic disease will be excluded.
Primary outcome:
Shivering episodes will be scored with the Shivering Assessment Scale.
Secondary outcome:
Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and
total energy needed during the cooling period will be compared between the two groups.
Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum
levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.
Train-of-four will be performed to assess the depth of relaxation. Sedation will be
monitored via bispectral index; measurement of metabolic activity will be evaluated using
indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities.
Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
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