Postoperative Residual Paralysis
Conditions
Brief 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.
Interventions
DRUGsugammadex
sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)
Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
| Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
| Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
| Forced Vital Capacity (FVC) changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
| Swallow ability changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
| Hemogasanalysis parameters changes after placebo or sugammadex | 10 minutes after surgery and 5 minutes later | 10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration) |
Countries
Italy
Outcome results
None listed