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.

Study Overview

• Status: Completed
• Conditions: Postoperative Residual Paralysis
• Intervention / Treatment: Drug: sugammadex; Drug: Sodium chloride solution

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sugammadex	Drug: sugammadex; sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg); Other Names: Bridion
Placebo Comparator: Sodium chloride solution	Drug: Sodium chloride solution; Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Investigators: Study Director: Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei tumori - Milan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: December 31, 2011
• First Posted (Estimate): January 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 22, 2014
• Last Update Submitted That Met QC Criteria: April 20, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis
• Other Study ID Numbers: INT-66/11