Clinical Trials Directory

Trials / Completed

CompletedNCT03198637

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Poitiers University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Interventions

TypeNameDescription
DRUGCisatracurium's monitoring by TOF (train-of-four) WATCH device.Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.
DRUGclinical assessment

Timeline

Start date
2013-04-01
Primary completion
2018-05-01
Completion
2018-05-01
First posted
2017-06-26
Last updated
2018-05-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03198637. Inclusion in this directory is not an endorsement.