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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
20
sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)
Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
Forced Vital Capacity (FVC) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
Hemogasanalysis parameters changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
Swallow ability changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Time frame: 10 minutes after surgery and 5 minutes later
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