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

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Cisatracurium's monitoring by TOF (train-of-four) WATCH device.
clinical assessment
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring efficient, neuromuscular, blockade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monitoring

Clinical assessment

Arm Description

Neuromuscular Blockade's monitoring

No active monitoring of cisatracurium

Outcomes

Primary Outcome Measures

Reduction of individual cumulative dose in mg cisatracurium

Secondary Outcome Measures

Full Information

First Posted
June 10, 2016
Last Updated
May 29, 2018
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03198637
Brief Title
Comparison of Neuromuscular Blockade's Monitoring and Clinical Assessment During Cisatracurium Paralysis in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
efficient, neuromuscular, blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitoring
Arm Type
Experimental
Arm Description
Neuromuscular Blockade's monitoring
Arm Title
Clinical assessment
Arm Type
Active Comparator
Arm Description
No active monitoring of cisatracurium
Intervention Type
Drug
Intervention Name(s)
Cisatracurium's monitoring by TOF (train-of-four) WATCH device.
Intervention Description
Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.
Intervention Type
Drug
Intervention Name(s)
clinical assessment
Primary Outcome Measure Information:
Title
Reduction of individual cumulative dose in mg cisatracurium
Time Frame
through study completion : from 1 to 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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