NCT02256280.

Trial name or title	A randomized double blind controlled trial comparing sugammadex and neostigmine after thoracic anaesthesia (DATA)
Methods	Allocation: randomized Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, caregiver, investigator)
Participants	Estimated enrolment: 266 Inclusion criteria: Scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis Age 18 to 70 years ASA class I, II, III BMI = 18 to 30 kg/m2 Exclusion criteria: Scheduled for oesophagectomy, thoracotomy, vascular resection COPD GOLD class III or IV, respiratory infection, asthma Preoperative FEV1 < 60% of predicted, FEV1/forced vital capacity ratio (FEV1/FVC) < 70% Preoperative diffusion lung capacity for carbon monoxide/alveolar volume ratio (DLCO/VA) < 60% of predicted Preoperative oxygen saturation (SpO2) < 92% or partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio < 300 Cardiovascular disease with metabolic equivalent of tasks (METS) score < 4 Neuromuscular disorder Kidney failure defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1,73 m2 Pregnant women
Interventions	Sugammadex 2 or 4 mg/kg IV once at completion of surgery Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) IV once at completion of surgery
Outcomes	Primary outcome measures: Mean time from reversal administration to TOFR = 0.9 [Time Frame: at the end of general anaesthesia] [Designated as safety issue: no] Time from reversal administration to at least 3 TOFR ≥ 0.9 Secondary outcome measures: Mean time from reversal administration to TOFR = 1.0 [Time Frame: at the end of general anaesthesia] [Designated as safety issue: no] Time from reversal administration to at least 3 TOFR value ≥ 1.0 Mean time from reversal administration to extubation [Time Frame: at the end of anaesthesia] [Designated as safety issue: no] Time from reversal administration to tracheal extubation Muscular weakness incidence [Time Frame: in the first 60 minutes after extubation] [Designated as safety issue: yes] Measured by tongue depressor test Hypoxaemia or hypercapnia incidence [Time Frame: in the first 60 minutes after extubation] [Designated as safety issue: yes] Hypoxaemia 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 Adverse events incidence [Time Frame: in the first 60 minutes after extubation] [Designated as safety issue: yes] Incidence of nausea or vomiting, abdominal pain, cardiac arrhythmias, hypotension coded according to Medical Dictionary for Regulatory Activities (MedDRA) terminology Postoperative complications incidence [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days] [Designated as safety issue: yes] Incidence of medical and surgical complications coded according to MedDRA terminology Other outcome measures: Mean time of hospital discharge [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days] [Designated as safety issue: no] Time from intervention date to hospital discharge Postoperative complications incidence [Time Frame: at 30 days after surgery] [Designated as safety issue: yes] Incidence of medical and surgical complications coded according to MedDRA terminology
Starting date	January 2015
Contact information	Contact: Federico Piccioni, MD, +39223902282: federico.piccioni@istitutotumori.mi.it Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Notes	This study is currently recruiting participants. Estimated Study Completion Date: July 2017