Comparison of Neuromuscular Blockade's Monitoring and Clinical Assessment During Cisatracurium Paralysis in Critically Ill Patients

Study Overview
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Brief Summary
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The main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression. The use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. Its interest is subject to a recommendation grade B and its use in prevention of overdose is associated with a recommendation of Grade C. However, many practitioners continue to objectify the depth of neuromuscular blockade and reversal by simple clinical evaluation. This is a subjective estimate of the depth of neuromuscular block. Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug distribution volume is usually increased in the Intensive Care patient and requires an increase in initial doses to obtain the same pharmacological effect. Then, unlike a short-term administration, the administration of neuromuscular blocking agents on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower which contributes to the increase of the elimination period after interruption of the administration of curare. There is therefore a risk of residual paralysis. Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte disorders and acid-base, administration of certain drugs, the inter- and intra-individual variability and tachyphylaxis (form tolerance of particularly rapid installation during a few close administration, linked to the proliferation of cholinergic receptors). The value of monitoring neuromuscular blockade in intensive care is the prevention of overdose and in finding the lowest effective dose.

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device.
* Drug: clinical assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Mechanically ventilated patients Indication for prescribing curare extended less than 1 day Sedation Information form waived by family members or surrogates Exclusion Criteria: Pregnancy, Curare infusion ongoing Neuromuscular disorders Dermal alteration Allergy to cisatracurium, atracurium, benzene sulfonic acid Expected survival of less than 2 days Personal or family history of malignant hyperthermia No social security Patient under enhanced protection Patient participating to an other intervention research or participated within 30 days

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring<br>Neuromuscular Blockade's monitoring | Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device.<br>* Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.<br>|
| Active Comparator: Clinical assessment<br>No active monitoring of cisatracurium | Drug: clinical assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of individual cumulative dose in mg cisatracurium |  | through study completion : from 1 to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficient, neuromuscular, blockade