NCT01503840

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%. Patients will perform pulmonary function tests (PFTs): * the day ahead of surgery (for elegibility and training) * 60 minutes before surgery * 10 minutes after extubation * 5 minutes after sugammadex or placebo administration * 20 minutes after sugammadex or placebo administration. The following parameters will be evaluated and compared between the 2 groups: * Maximal Inspiratory Pressure (MIP) * Maximal Expiratory Pressure (MEP) * Forced Expiratory Volume in the first Second (FEV1) * Forced Vital Capacity (FVC) * Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) * PaO2, PaCO2, pH * heart rate, blood pressure and respiratory rate Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.

Conditions

• Postoperative Residual Paralysis

Interventions

Type	Name	Description
DRUG	sugammadex	sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)
DRUG	Sodium chloride solution	Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2012-01-04
• Last updated: 2014-04-22

Locations

1 site across 1 country: Italy