Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest

Medical University of Vienna

Status: Completed

Conditions: Critical Illness; Cardiac Arrest

Treatments: Drug: Placebo; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT01683006

753/2009UH

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.

Full description

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. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated.

Aim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin

Exclusion criteria

• age < 18
• 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
• patients with known epileptic disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

Neuromuscular blocker group

Active Comparator group

Description:

Continuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering.

Treatment:

Drug: Rocuronium

Placebo group

Placebo Comparator group

Description:

Continuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering.

Treatment:

Drug: Placebo