Safety and Feasibility of a New Neuromuscular Monitoring Device

Study Overview
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Brief Summary
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The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery. The two devices will be studied simultaneously in each patient.

Official Title
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Safety and Feasibility of a New Neuromuscular Monitoring Device

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: Isometric Trumb Force handle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, ASA class 1 to 3, Scheduled for elective surgery requiring general anesthesia and muscle paralysis Exclusion Criteria: Age inferior to 18 years, ASA class 4, Emergency surgery, Prone position on the operating table

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right Isometric Thumb Force (ITF) handle<br> | Device: Isometric Trumb Force handle<br>* Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.<br>|
| Experimental: Left Isometric Thumb Force (ITF) handle<br> | Device: Isometric Trumb Force handle<br>* Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four | We compare the response to curare with one side a conventional TOF Watch SX monitor and other side Handle Isometric Thumb Force. | Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical examination | Appearance of the wrist skin (for example: redness, irritations or marks) | the first 24 postoperative hours | 
| Clinical examination | Wrist pain | the first 24 postoperative hours | 
| Characteristics of maintenance curarization | Value of the post-tetanus count at the time of administration of an extra bolus of rocuronium and the number of muscle contractions in response to a four-train stimulation | Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time. | 
| Characteristics of decurarization during spontaneous recovery phase | Delay of the gear ratio from train of four to 25; 75 and 90%. | Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time. | 
| When the TOF ratio will be greater than 0.9 on the TOF Watch side, the degree of residual paralysis will be assessed on the ITF side using 100 Hz tetanus stimulation repeated 5 times at 2 minutes interval | The response of theses tetanus stimulations will be compared with the one observed before myorelaxant administration but after induction of anesthesia | Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time. |