ClinicalTrials.Veeva

Menu

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

P

Poitiers University Hospital

Status and phase

Completed
Phase 3

Conditions

Critical Illness

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03198637
MONITOR

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Monitoring
Experimental group
Description:
Neuromuscular Blockade's monitoring
Treatment:
Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device.
Clinical assessment
Active Comparator group
Description:
No active monitoring of cisatracurium
Treatment:
Drug: clinical assessment

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems