Neuromuscular Monitoring:TOFCuff Versus EMG
Condition: Neuromuscular Blockade
Study type: Observational

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.
    

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.
    

Observational model: Case-Control
Time perspective: Prospective
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.