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Prediction of the Recovery of Neuromuscular Transmission After Curarization

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ClinicalTrials.gov Identifier: NCT03550664
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Denis SCHMARTZ, Brugmann University Hospital

Brief Summary:

The vast majority of patients receive neuromuscular blockers during surgical procedures, either as a single injection to facilitate intubation or as repeated injections to induce muscle relaxation necessary for surgery. The action of neuromuscular blockers is monitored by measuring the contraction force of the adductor of the thumb after stimulation of the ulnar nerve.Different types of stimulation, such as train-of-four (TOF), post- Tetanus count (PTC), double-burst stimulation (DBS) measure different degrees of curarization.The duration of action of neuromuscular blockers has significant interindividual variability. If the investigators know how to measure the degree of curarization of a patient at a given time, it is difficult to know how long it will take to recover neuromuscular function.

The purpose of this study is to determine if the individual recovery of a patient can be predicted form data obtained at the beginning of his/her recovery curve. The investigators propose to record all neuromuscular transmission monitoring data in 100 patients. From these data, the investigators will try to develop an algorithm that would extrapolate the recovery curve of an isolated patient from the fist neuromuscular monitoring data.


Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Device: Monitoring of neuromuscular transmission Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prediction of the Recovery of Neuromuscular Transmission After Curarization, Pilot Study
Actual Study Start Date : June 12, 2018
Actual Primary Completion Date : June 20, 2020
Actual Study Completion Date : June 20, 2020

Arm Intervention/treatment
Experimental: Surgical intervention
Patients undergoing a surgical intervention within the CHU Brugmann with utilisation of rocuronium.
Device: Monitoring of neuromuscular transmission
Monitoring of neuromuscular transmission will be done by TOFScan (IdMed, Marseille, France). This device is CE marked, and is used routinely in daily clinical practice. Prior to induction of anesthesia, the TOFScan is placed on a patient's hand and the two stimulation electrodes (ECG electrodes) are placed at the level of the ulnar nerve at the wrist. After induction of anesthesia and before administration of a curare, the TOFScan is calibrated according to the manufacturer's instructions. The TOFScan is placed in automatic mode, it will then automatically adapt its mode of stimulation to the depth of the curarization. The TOFScan measurements will be recorded on a PC connected to the TOFScan.




Primary Outcome Measures :
  1. TOFScan recording [ Time Frame: 1 day ]
    Recordings of the TOFScan device (monitoring of the neuro-muscular transmission) during the entire length of the surgery are automatically stored on PC. This data will be used to conceive a mathematical algorithm predicting the decurarisation curve of an individual patient.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing a surgical intervention with rocuronium
  • Patients covered by the Belgian social security system

Exclusion Criteria:

  • Allergy towards rocuronium
  • 20< Body Mass Index <30
  • Hepatocellular insufficiency, either clinical or abnormal liver tests
  • Renal insufficiency, defined as Modification of diet in renal disease (MDRD) <40ml / min or Cockgroft <50ml / min
  • Need to antagonize the curare

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550664


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Denis Schmartz, MD CHU Brugmann
Additional Information:
Publications:
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Responsible Party: Denis SCHMARTZ, Head of the Anesthesiology department, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03550664    
Other Study ID Numbers: CHUB-NMB recovery
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No