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

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Neuromuscular Monitoring
Curarisation

Treatments

Drug: Rocuronium
Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Study type

Interventional

Funder types

Other

Identifiers

NCT02880787
2014-A00540-47

Details and patient eligibility

About

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%.

Enrollment

142 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

142 participants in 4 patient groups

Adult population 1
Other group
Description:
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Treatment:
Drug: Rocuronium
Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®
Adult population 2
Other group
Description:
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Treatment:
Drug: Rocuronium
Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®
Pediatric population 1
Other group
Description:
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Treatment:
Drug: Rocuronium
Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®
Pediatric population 2
Other group
Description:
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Treatment:
Drug: Rocuronium
Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Trial contacts and locations

1

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Central trial contact

Thomas FUCHS-BUDER, Pr

Data sourced from clinicaltrials.gov

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