Completed

NCT Number: NCT01503840

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.

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Key information

Conditions

Postoperative Residual Paralysis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)

Other names: Bridion

Sodium chloride solution

Drug

Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.

Primary outcomes

Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 10 minutes after surgery and 5 minutes later

10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)

Secondary outcomes

Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex

Time frame: 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

Time frame: 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

Time frame: 10 minutes after surgery and 5 minutes later

10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jan 4, 2012
Registry last updated: Apr 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.