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CompletedNCT03198637Updated May 31, 2018

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

A Phase 3 interventional study of Cisatracurium's monitoring by TOF (train-of-four) WATCH device. and clinical assessment in Critical Illness, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Poitiers University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Critical Illness

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Keywords

  • efficient
  • neuromuscular
  • blockade
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Monitoring

    Neuromuscular Blockade's monitoring

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

  • Active comparator
    Clinical assessment

    No active monitoring of cisatracurium

    Drug: clinical assessment

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
06

What researchers measure

Primary outcomes

  1. Reduction of individual cumulative dose in mg cisatracurium

    Time frame: through study completion : from 1 to 20 days

07

Study locations

1 site
  • CHU de Poitiers
    Poitiers, 86021, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03198637
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Jun 26, 2017
Start date
Apr 2013
Primary completion
May 2018
Completion
May 2018
Last update
May 31, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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