Postoperative Residual Paralysis Clinical Trial
Official title:
Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate
residual postoperative paralysis but it represents the most simple, inexpensive and
widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered
the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based
neuromuscular monitoring in order to exclude postoperative residual paralysis which is not
highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function
tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF
ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although
the monitoring device shows a complete decurarization; patients treated with sugammadex
should not be capable to perform better pulmonary function tests if a TOF ratio=100% is
reliable.
From the beginning of the surgery to the time of extubation neuromuscular block is monitored
with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital
capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared
between study groups.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)