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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Completed

Conditions: Postoperative Residual Paralysis

Treatments: Drug: sugammadex; Drug: Sodium chloride solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01503840

INT-66/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups, including a placebo group

Sugammadex

Active Comparator group

Treatment:

Drug: sugammadex

Sodium chloride solution

Placebo Comparator group

Treatment:

Drug: Sodium chloride solution