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

• Status: Terminated
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Neostigmine

Criteria

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