Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

Study Overview
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Brief Summary
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The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population. Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for: the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6) complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.

Official Title
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Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

Conditions
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Curarisation, Neuromuscular Monitoring

Intervention / Treatment
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* Drug: Rocuronium
* Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult population: Non opposition to research > 18 years old ASA score 1-3 Undergoing surgery with curarisation through tracheal intubation Affiliation to social security Pediatric population: > 1 year old Non opposition to research of child (if able to consent) or representatives with parental authority ASA score 1-4 Undergoing surgery with curarisation Affiliation to social security Exclusion Criteria: Adult population: Allergy to administered drugs Known or suspected difficult intubation Pregnant women BMI > 40 Pediatric population: Allergy to administered drugs Known or suspected difficult intubation

Ages Eligible for Study
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Minimum Age: 1 Year

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adult population 1<br>TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm | Drug: Rocuronium<br>* Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)<br>Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®<br>* Each monitor on one arm<br>|
| Other: Adult population 2<br>TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm | Drug: Rocuronium<br>* Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)<br>Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®<br>* Each monitor on one arm<br>|
| Other: Pediatric population 1<br>TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm | Drug: Rocuronium<br>* Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)<br>Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®<br>* Each monitor on one arm<br>|
| Other: Pediatric population 2<br>TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm | Drug: Rocuronium<br>* Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)<br>Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®<br>* Each monitor on one arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia | 
| Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX |  | day 0, after induction of anesthesia |