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

NCT ID: NCT03198637

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-05-31

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.

Conditions

Critical Illness

Keywords

efficient; neuromuscular; blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monitoring

Neuromuscular Blockade's monitoring

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.

Clinical assessment

No active monitoring of cisatracurium

Group Type: ACTIVE_COMPARATOR

clinical assessment

Intervention Type: DRUG

Interventions

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

Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.

Intervention Type: DRUG

clinical assessment

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

MONITOR

Identifier Type: -

Identifier Source: org_study_id