A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
- Registration Number
- NCT02256280
- Lead Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
- Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
- Age 18-70 years
- American Society of Anesthesiologists (ASA) class 1, 2, 3
- Body mass Index (BMI) = 18-30 kg/m2
- Subjects scheduled for esophagectomy, thoracectomy, vascular resection
- Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
- Preoperative Forced Expiratory Volume in 1 second (FEV1) < 60% of predicted, Forced Expiratory Volume in 1 second/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 less than 4
- Neuromuscular disorder
- Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1,73 m2
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S Group Sugammadex Sugammadex 2 or 4 mg/kg iv once at the end of surgery N Group Neostigmine Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery
- Primary Outcome Measures
Name Time Method Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9 At the end of general anesthesia Time from reversal administration to at least 3 TOF-ratio value = or \> 0.9
- Secondary Outcome Measures
Name Time Method Mean time from reversal administration to TOF-ratio = 1.0 At the end of general anesthesia Time from reversal administration to at least 3 TOF-ratio value = or \> 1.0
Mean time from reversal administration to extubation At the end of anesthesia Time from reversal administration to tracheal extubation
Muscular weakness incidence In the first 60 minutes after extubation Measured by the tongue depressor test
Hypoxemia or hypercapnia incidence In the first 60 minutes after extubation 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.
Adverse events incidence In the first 60 minutes after extubation Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology
Postoperative complications incidence Participants will be followed for the duration of hospital stay, an expected average of 7 days Incidence of medical and surgical complications coded according to the MedDRA terminology
Trial Locations
- Locations (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milan, Mi, Italy