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
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring efficient, neuromuscular, blockade
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
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
NCT ID
NCT03198637
First Posted
June 10, 2016
Last Updated
May 29, 2018
Sponsor
Poitiers University Hospital
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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