Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest (RELAX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01719770|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : May 1, 2015
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.
Shivering episodes will be scored with the Shivering Assessment Scale.
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest With Successful Resuscitation Hypothermia Skeletal Muscle Relaxant Overdose||Drug: rocuronium Other: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Requirement of Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest - a Pilot Study|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||April 2015|
Active Comparator: Rocuronium
Continuous infusion of rocuronium with 0,25mg/kg (blinded) for 29 hours after initiation of mild therapeutic hypothermia
continuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)
Other Name: Esmeron
Placebo Comparator: Placebo
Continuous infusion of sodium-chloride (placebo) and rocuronium bolus (0,25mg/kg)in case of shivering episode (blinded)
continuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)
Other Name: sodium-chloride
- Number of shivering episodes [ Time Frame: during cooling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours ]Shivering episodes will be detected according to the Shivering Assessment Scale
- Elapsed time to target temperature [ Time Frame: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation ]
- Dissipated energy to reach the target temperature [ Time Frame: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation ]
- Changes in basal metabolism due to shivering or elevated stress levels [ Time Frame: during the first 72 hours after cardiac arrest ]
- Depth of relaxation [ Time Frame: during cooling and rewarming period, which will be approximately 30 hours up to 48 hours after initiation of cooling ]via train of four measurement
- Changes in serum levels of midazolam, fentanyl and rocuronium [ Time Frame: within the first 48 hours of treatment ]
- Number of necessary boli of rocuronium [ Time Frame: during colling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours ]In case of a shivering episode, a bolus of rocuronium will be administered (0,25mg/kg)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719770
|Medical University of Vienna, Department of Emergency Medicine|
|Vienna, Austria, 1190|
|Principal Investigator:||Heidrun Losert, MD||Medical University Vienna, Department of Emergency Medicine|