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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03198637
Enrollment
50
Registered
2017-06-26
Start date
2013-04-30
Completion date
2018-05-31
Last updated
2018-05-31

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

Conditions

Critical Illness

Keywords

efficient, neuromuscular, blockade

Brief 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.

Interventions

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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction of individual cumulative dose in mg cisatracuriumthrough study completion : from 1 to 20 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026