Requirement of Skeletal Muscle Paralysis in Hypothermic Patients after Cardiac Arrest. A pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015771-27-AT

Enrollment

Unknown

Registered

2010-01-13

Start date

2010-01-21

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

skeletal muscle paralysis in hypothermic patients after cardiac arrest

Interventions

Trade Name: ROCURONIUMBROMID Kabi 10 mg/ml - Inj-/Inf-Lsg Product Name: ROCURONIUMBROMID Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ROCURONIUM Concentration unit: mg/kg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All Patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients younger than 18 years, • Known or clinically apparent pregnancy, • Patients who reach our hospital with a body temperature below 35°C, • Patients with known allergic reaction against rocuronium, • Patients with a history of myasthenia gravis, • Patients with obvious intoxication, • Ward of the state / Prisoner, • Known epileptic disease, • Cardiac arrest >6 hours prior to hospital admission.

Design outcomes

Primary

Measure	Time frame
Main Objective: Number of shivering episodes will be assessed and compared between the two groups with the Shivering Assessment Scale and the EMG.;Secondary Objective: • The number of necessary rocuronium boli will be counted as well as the totally administered dose of rocuronium bromide in both groups. • Elapsed time to target temperature. We want to evaluate whether patients without continuous relaxation need a longer time to reach the target temperature of 33°C. • Dissipated energy to reach the target temperature. Cooling rate and necessary energy will be recorded by the Alsius® Coolgard device, as described in detail in section “treatment and interventions”. • Differences in basal metabolism due to shivering or elevated stress levels will be measured by indirect calorimetry. • Depth of relaxation (especially during rewarming and the following hours) to detect an “overhang” of rocuronium. • Serum levels of midazolam, fentanyl and rocuronium. • Serum levels of stress hormones will be measured. • All patients will be monitored with continuous EEG to detect seizures;Primary end point(s): Shivering episodes will be scored with the Shivering Assessment Scale and EMG.	—

Measure

Time frame

Main Objective: Number of shivering episodes will be assessed and compared between the two groups with the Shivering Assessment Scale and the EMG.;Secondary Objective: • The number of necessary rocuronium boli will be counted as well as the totally administered dose of rocuronium bromide in both groups. • Elapsed time to target temperature. We want to evaluate whether patients without continuous relaxation need a longer time to reach the target temperature of 33°C. • Dissipated energy to reach the target temperature. Cooling rate and necessary energy will be recorded by the Alsius® Coolgard device, as described in detail in section “treatment and interventions”. • Differences in basal metabolism due to shivering or elevated stress levels will be measured by indirect calorimetry. • Depth of relaxation (especially during rewarming and the following hours) to detect an “overhang” of rocuronium. • Serum levels of midazolam, fentanyl and rocuronium. • Serum levels of stress hormones will be measured. • All patients will be monitored with continuous EEG to detect seizures;Primary end point(s): Shivering episodes will be scored with the Shivering Assessment Scale and EMG.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026