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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.
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 following parameters will be evaluated and compared between the 2 groups:
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Active Comparator |
| |
| Sodium chloride solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sugammadex | Drug | sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Piccioni, MD | Fondazione IRCCS Istituto Nazionale dei Tumori - Milan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24740312 | Result | Piccioni F, Mariani L, Bogno L, Rivetti I, Tramontano GT, Carbonara M, Ammatuna M, Langer M. An acceleromyographic train-of-four ratio of 1.0 reliably excludes respiratory muscle weakness after major abdominal surgery: a randomized double-blind study. Can J Anaesth. 2014 Jul;61(7):641-9. doi: 10.1007/s12630-014-0160-7. Epub 2014 Apr 17. |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Sodium chloride solution | Drug | Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v. |
|
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 |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |