A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia

Study Overview
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Brief Summary
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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
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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

Official Title
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Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S Group<br>Sugammadex 2 or 4 mg/kg iv once at the end of surgery | Drug: Sugammadex<br>* 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<br>* Other names: Bridion;|
| Active Comparator: N Group<br>Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery | Drug: Neostigmine<br>* 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.<br>* Other names: Intrastigmina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At the end of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time from reversal administration to TOF-ratio = 1.0 | Time from reversal administration to at least 3 TOF-ratio value = or > 1.0 | At the end of general anesthesia | 
| Mean time from reversal administration to extubation | Time from reversal administration to tracheal extubation | At the end of anesthesia | 
| Muscular weakness incidence | Measured by the tongue depressor test | 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. | 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 | In the first 60 minutes after extubation | 
| Postoperative complications incidence | Incidence of medical and surgical complications coded according to the MedDRA terminology | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular blockade, Thoracic surgery