Postoperative Residual Paralysis Clinical Trial
Official title:
Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Italy,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |