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

Critical Illness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198637
• Other study ID #: MONITOR
• Status: Completed
• Phase: Phase 3
• Start date: April 2013
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.
• clinical assessment

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of individual cumulative dose in mg cisatracurium		through study completion : from 1 to 20 days