Comparison of Neuromuscular Blockade's Monitoring and Clinical Assessment During Cisatracurium Paralysis in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT03198637|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : May 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device. Drug: clinical assessment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
Neuromuscular Blockade's monitoring
Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device.
Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.
Active Comparator: Clinical assessment
No active monitoring of cisatracurium
Drug: clinical assessment
- Reduction of individual cumulative dose in mg cisatracurium [ Time Frame: through study completion : from 1 to 20 days ]
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): NCT03198637
|CHU de Poitiers|
|Poitiers, France, 86021|