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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Residual Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sugammadex

Group Type ACTIVE_COMPARATOR

sugammadex

Intervention Type DRUG

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

Sodium chloride solution

Group Type PLACEBO_COMPARATOR

Sodium chloride solution

Intervention Type DRUG

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

Interventions

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sugammadex

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

Intervention Type DRUG

Sodium chloride solution

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

Intervention Type DRUG

Other Intervention Names

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Bridion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No