Clinical trial NCT01503840: Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Official title: Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Residual Paralysis
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
measure: Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
measure: Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
measure: Forced Vital Capacity (FVC) changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
Secondary outcomes:
measure: Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
measure: Hemogasanalysis parameters changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
measure: Swallow ability changes after placebo or sugammadex
timeFrame: 10 minutes after surgery and 5 minutes later
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
name: Federico Piccioni, MD
role: STUDY_DIRECTOR
References:
citation: 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.