drugset / Trial / NCT02256280

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

NCT02256280

RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2015-01
Primary completion
2020-03
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Neostigmine Other / unclassified 0.05 mg/kg Intravenous
Comparator Neostigmine Other / unclassified 0.07 mg/kg Intravenous
Subject Sugammadex Other / unclassified 2 mg/kg Intravenous
Subject Sugammadex Other / unclassified 4 mg/kg Intravenous
Comparator Atropine Other / unclassified 0.02 mg/kg Intravenous

Indications

No indication recorded.