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Neuromuscular Monitoring:TOFCuff Versus EMG

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ClinicalTrials.gov Identifier: NCT04282213
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Lorena Silva Gil, Servei Central d' Anestesiologia

Brief Summary:
Mechanomyography (MMG) is considered the gold-standard for neuromuscular blockade (NMB) monitoring. However, it is quite bulky and difficult to use on a routine basis. Therefore, alternative methods like Acceleromyography (AMG), Electromyography (EMG) and the TOF-CUFF method have been developed. The aim of this study was to compare the TOF-Cuff monitor and Electromyography (EMG-NMT module with the CARESCAPE B450 monitor) data following rocuronium-induced neuromuscular blockade and its reversal.

Condition or disease
Neuromuscular Blockade

Detailed Description:

Neuromuscular relaxation of the patient during surgery is necessary for multiple reasons, such as facilitating intubation or improving the effectiveness of some surgical procedures. Premature extubation of the patient without having achieved a complete recovery of the NMB can have deleterious consequences, increasing postoperative complications, especially those related to the respiratory system. Given this, current guidelines of good clinical practice recommend the monitoring of pharmacologically induced NMB during general anesthesia. In addition, monitoring allows confirmation of optimum relaxation before intubation, and allows for control over re-dose administration and recovery of NMB upon awakening from general anesthesia.

There are different methods of quantitative monitoring of NMB. The TOF-CUFF monitor uses a method based on a traditional pressure cuff that incorporates stimulation electrodes. The placement of the cuff which aligns the stimulation electrodes on the path of the brachial plexus at the humeral level allows to evaluate the muscular response evoked from the changes in the cuff pressure, generated by the muscular contraction after the electrical stimulus. Its main advantage is that monitoring of the NMB is included within the pressure cuff itself, which is always used in any anesthetic act. Then, when the pressure cuff is placed, monitoring of the NMB is easily established. This specific design facilitates the task of anesthesiologists because they do not have to perform any additional preparation for the monitoring of NMB.

The TOF-CUFF monitor has been validated regarding the mechanomyography, which is considered the gold-standard for the monitoring of NMB. The main objective of the study is to compare the values of NMB measured with the TOF-CUFF monitor with NMB values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence in different situations. Secondary objective is to verify that the design for joint monitoring of the NMB and NIBP in the TOF-CUFF monitor does not affect the independent measure of the two variables.

Prospective, single-center, open and controlled observational clinical study. The study is aimed to be conducted with 40 patients aged between 18 and 65 years.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the TOFCuff Monitor Versus Electromyography in Neuromuscular Monitoring
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : May 10, 2020

Group/Cohort
Control samples
For each case, neuromuscular measurements gathered with GE CARESCAPE B450 monitor (E-NMT module).
Case samples
For each case, neuromuscular measurements gathered with TOFCuff monitor.



Primary Outcome Measures :
  1. TOFR (Train Of Four Ratio) [ Time Frame: Baseline ]

    For this measurement, patient is stimulated with four twitches at a known stimulation current. Each twitch is performed every 500ms. The neuromuscular response for each twitch is gathered. Train Of Four ratio consists of the weighting of the fourth stimulus against the first stimulus.

    It can be calculated also as a percentage.


  2. Counts [ Time Frame: Baseline ]
    When performing the Train Of Four (TOF) measurement, count of the twitches that are higher than 0.

  3. PTC [ Time Frame: Baseline ]

    Once patient is in a deep neuromuscular blockade, all twitches from Train Of Four (TOF) measurement are 0. In order to evaluate the neuromuscular response, Post Tetanic Count (PTC) measurement is performed.

    PTC is splitted in two steps. First, during 5 seconds a tetanic stimulation is performed at 50Hz. If no response is elicited, after a pause of 3 seconds 15 single-twitch stimualtion at 1Hz are performed. PTC value is the count of the single-twitches that are higher than 0.


  4. T1 [ Time Frame: Baseline ]
    For Train Of Four (TOF) measurement, amplitude of the first neuromuscular stimulation response. Units depend on the measurement techniques.

  5. T2 [ Time Frame: Baseline ]
    For Train Of Four (TOF) measurement, amplitude of the second neuromuscular stimulation response. Units depend on the measurement techniques.

  6. T3 [ Time Frame: Baseline ]
    For Train Of Four (TOF) measurement, amplitude of the third neuromuscular stimulation response. Units depend on the measurement techniques.

  7. T4 [ Time Frame: Baseline ]
    For Train Of Four (TOF) measurement, amplitude of the fourth neuromuscular stimulation response. Units depend on the measurement techniques.

  8. PID [ Time Frame: Baseline ]
    Diastolic pressure in mmHg

  9. PIS [ Time Frame: Baseline ]
    Systolic pressure in mmHg

  10. PIM [ Time Frame: Baseline ]
    Mean pressure in mmHg


Secondary Outcome Measures :
  1. Temperature [ Time Frame: Baseline ]
    Patient temperature on the palm hand



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients American Society of Anesthesiologist (ASA) I-II, between 18-65 years and scheduled for elective surgery under general anesthesia.
Criteria

Inclusion Criteria:

  • ASA I-II
  • Patients who give their written informed consent
  • Elective surgery under general anesthesia that according to the anesthetic plan muscle relaxants will be administered

Exclusion Criteria:

  • Patients who refuse to give their informed consent
  • Patients who present any of the contraindications for the devices used in the study
  • Patients who are participating or have participated in a clinical trial during the 4 weeks prior to inclusion
  • Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or breast-feeding
  • Patients with the following criteria: upper limb peripheral vascular pathologies, a difficult airway, myasthenia gravis and other neuromuscular diseases, use of medication that may alter NMT

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): NCT04282213


Contacts
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Contact: Lorena Silva Gil, MD 932906005 lsilva@anestalia.com

Locations
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Spain
Centro Médico Teknon Recruiting
Barcelona, Spain, 08022
Contact: Lorena Silva Gil, MD    932906005    lsilva@anestalia.com   
Sub-Investigator: Carlos Rafael Ramírez Paesano, MD         
Sub-Investigator: Ferran Callicó Ros, Eng         
Sub-Investigator: Sara Julián González, MSc         
Sponsors and Collaborators
Servei Central d' Anestesiologia
Investigators
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Principal Investigator: Lorena Silva Gil, MD Servei d'Anestesiologia Centro Médico Teknon
Publications:
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Responsible Party: Lorena Silva Gil, Principal Investigator, Servei Central d' Anestesiologia
ClinicalTrials.gov Identifier: NCT04282213    
Other Study ID Numbers: NMT2020
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 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