NCT02256280

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex	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
DRUG	Neostigmine	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2014-10-03
• Last updated: 2021-06-16

Locations

1 site across 1 country: Italy