At the end of anesthesia it's important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is to verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery). Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.
Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent. Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as follows: Sugammadex group: * If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg * If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg Neostigmine group: * If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg * If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
70
Sugammadex will be diluted in a saline water solution in a 10 mL syringe. Administration will be according to the neuromuscular blockade: * If Post tetanic count = 1-15: 4 mg/kg * If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg
Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe. Administration will be according to the neuromuscular blockade: * If Post tetanic count = 1-15: 0.07 mg/kg * If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage.
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Mi, Italy
Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
Time from reversal administration to at least 3 TOF-ratio value = or \> 0.9
Time frame: At the end of general anesthesia
Mean time from reversal administration to TOF-ratio = 1.0
Time from reversal administration to at least 3 TOF-ratio value = or \> 1.0
Time frame: At the end of general anesthesia
Mean time from reversal administration to extubation
Time from reversal administration to tracheal extubation
Time frame: At the end of anesthesia
Muscular weakness incidence
Measured by the tongue depressor test
Time frame: In the first 60 minutes after extubation
Hypoxemia or hypercapnia incidence
Hypoxemia defined as Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen ratio (PaO2/FiO2) \< 300. Hypercapnia defined as Partial pressure of carbon dioxide in arterial blood (PaCO2) \> 45 mmHg.
Time frame: In the first 60 minutes after extubation
Adverse events incidence
Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology
Time frame: In the first 60 minutes after extubation
Postoperative complications incidence
Incidence of medical and surgical complications coded according to the MedDRA terminology
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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