drugset / Trial / NCT01503840

Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis

NCT01503840

RandomizedParallel-groupTriple-blind

Summary

Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization). This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%. The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.

Timeline

Start
2011-12
Primary completion
2012-06
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sugammadex Other / unclassified 1 mg/kg Intravenous

Indications