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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Residual Paralysis

Intervention / Treatment
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* Drug: sugammadex
* Drug: Sodium chloride solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing major abdominal surgery age between 18 and 70 years ASA class 1 or 2 patients scheduled for blended anesthesia (epidural + general anesthesia) patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges). Exclusion Criteria: known or suspected respiratory, cardiovascular or neuromuscular disease renal or hepatic failure known or suspected allergies to drugs used in the study risk for malignant hyperthermia pregnancy diagnosed depressive disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugammadex<br> | Drug: sugammadex<br>* sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)<br>* Other names: Bridion;|
| Placebo Comparator: Sodium chloride solution<br> | Drug: Sodium chloride solution<br>* Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later | 
| Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later | 
| Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later | 
| Forced Vital Capacity (FVC) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later | 
| Hemogasanalysis parameters changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later | 
| Swallow ability changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) | 10 minutes after surgery and 5 minutes later |