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

Not Applicable

Completed

• Conditions: Postoperative Residual Paralysis
• Interventions: Drug: sugammadex; Drug: Sodium chloride solution

• Registration Number: NCT01503840
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-31
• Study First Posted: 2012-01-04
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-20
• Last Update Posted: 2014-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	sugammadex	-
Sodium chloride solution	Sodium chloride solution	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy