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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

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%.

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Detailed Description

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Conditions

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Curarisation Neuromuscular Monitoring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adult population 1

TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm

Group Type OTHER

Rocuronium

Intervention Type DRUG

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)

Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Intervention Type DEVICE

Each monitor on one arm

Adult population 2

TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm

Group Type OTHER

Rocuronium

Intervention Type DRUG

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)

Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Intervention Type DEVICE

Each monitor on one arm

Pediatric population 1

TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm

Group Type OTHER

Rocuronium

Intervention Type DRUG

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)

Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Intervention Type DEVICE

Each monitor on one arm

Pediatric population 2

TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm

Group Type OTHER

Rocuronium

Intervention Type DRUG

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)

Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Intervention Type DEVICE

Each monitor on one arm

Interventions

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Rocuronium

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)

Intervention Type DRUG

Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Each monitor on one arm

Intervention Type DEVICE

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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No