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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
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Critical Illness Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device. Drug: clinical assessment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Monitoring
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



Primary Outcome Measures :
  1. Reduction of individual cumulative dose in mg cisatracurium [ Time Frame: through study completion : from 1 to 20 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
CHU de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03198637     History of Changes
Other Study ID Numbers: MONITOR
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Keywords provided by Poitiers University Hospital:
efficient
neuromuscular
blockade
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Cisatracurium
Atracurium
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action