Status:
TERMINATED
A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 neuromus...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02256280
Start Date
January 1 2015
End Date
March 1 2020
Last Update
June 16 2021
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Mi, Italy, 20133