Neuromuscular block is commonly adopted during general anesthesia to facilitate tracheal intubation, mechanical ventilation and surgical manipulation. At the end of anesthesia it very 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.
Conditions
Interventions
Trade Name: Bridion
Product Name: Sugammadex
Product Code: S
Pharmaceutical Form: Injection
Trade Name: Intrastigmina
Product Name: Neostigmine
Product Code: N
Pharmaceutical Form: Injection
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects scheduled for pulmonary resection, lebectomy, pneumonectomy, bullectomy, pleurodesis - Age 18-70 years - ASA class 1,2,3 - Body Mass Index (BMI) 18-30 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: - Subject scheduled for esofagectomy, thoracectomy, vascular resection - COPD Gold class III and IV, respiratory infection, asthma - Preoperative FEV1 < 60% of predicted, FEV1/FVC<70% - Preoperative DLCO2/VA<60% of predicted - Preoperative SpO2<92%, PaO2/FiO2<300 - Cardiovascular desease with a METS score less than 4 - Neuromuscular disorder - Kidney insufficiency (eGFR<30 ml/min/1,73m2) - Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a TOF-ratio of 0.9 after thoracic anesthesia. TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.;Secondary Objective: Demonstrate that sugammadex allows a faster extubation. 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).;Primary end point(s): Time from reversal administration to TOF-ratio = 0.9 ;Timepoint(s) of evaluation of this end point: At the end of general anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time from reversal administration to TOF-ratio = 1.0 Time from reversal administration to extubation Adverse events and side effects incidence after extubation and in the postoperative period (until the 30th day after surgery) ;Timepoint(s) of evaluation of this end point: At the end of general anesthesia (time to extubation) Adverse events and side effects will be evaluated in the first 60 minutes after extubation, in the first 5 days after operation and at 30 days after surgery. | — |
Countries
Italy
Contacts
Public ContactS.C. Anestesia e Rianimazione
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed