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

Neuromuscular Blockade Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Neuromuscular Blockade

• NCT number: NCT02256280
• Study type: Interventional
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Status: Terminated
• Phase: Phase 4
• Start date: January 2015
• Completion date: March 2020