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Clinical Trials/NCT02880787
NCT02880787
Unknown
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country142 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Rocuronium
Conditions
Curarisation
Sponsor
Central Hospital, Nancy, France
Enrollment
142
Locations
1
Primary Endpoint
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Last Updated
9 years ago

Overview

Brief Summary

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%.
Registry
clinicaltrials.gov
Start Date
November 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Adult population 1

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

Intervention: Rocuronium

Adult population 1

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

Intervention: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Adult population 2

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

Intervention: Rocuronium

Adult population 2

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

Intervention: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Pediatric population 1

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

Intervention: Rocuronium

Pediatric population 1

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

Intervention: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Pediatric population 2

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

Intervention: Rocuronium

Pediatric population 2

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

Intervention: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Outcomes

Primary Outcomes

Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: day 0, after induction of anesthesia

Secondary Outcomes

  • 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)

Study Sites (1)

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