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

NCT03198637 | Completed Phase 3

• 1 other identifier: MONITOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduction of individual cumulative dose in mg cisatracurium

  through study completion : from 1 to 20 days

Study Arms (2)

Monitoring

EXPERIMENTAL

Neuromuscular Blockade's monitoring

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

Clinical assessment

ACTIVE COMPARATOR

No active monitoring of cisatracurium

Drug: clinical assessment

Interventions

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

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

Monitoring

clinical assessment DRUG

Clinical assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 26, 2017
• Study Start: April 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

FR (1)