ClinicalTrials.gg
Sign In
Status unknownNCT02880787TOFScanUpdated Aug 26, 2016

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

An interventional study of Rocuronium and Neuromuscular monitoring with TOFScan® and TOF-Watch SX® in Curarisation and Neuromuscular Monitoring, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2016-08-26.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Non-randomized
Ages
1 Year and older
Sex
All
01

Study 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%.
02

Conditions studied

  • Curarisation
  • Neuromuscular Monitoring
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 796 studies on the registry; 187 are open to participants now.

Browse Central Hospital, Nancy, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
142 participants (estimated)

Study arms

  • Other
    Adult population 1

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

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

  • Other
    Adult population 2

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

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

  • Other
    Pediatric population 1

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

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

  • Other
    Pediatric population 2

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

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

Interventions

  • DrugRocuronium

    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)

  • DeviceNeuromuscular monitoring with TOFScan® and TOF-Watch SX®

    Each monitor on one arm

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  1. 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

    Time frame: day 0, after induction of anesthesia

  2. 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

    Time frame: day 0, after induction of anesthesia

07

Study locations

1 of 1 sites recruiting
  • CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation
    Vandœuvre-lès-Nancy, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2014, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2016
First posted
Aug 26, 2016
Start
Nov 2014
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Aug 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02880787
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
Nov 2014
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Aug 26, 2016

Study contacts

Thomas FUCHS-BUDER, Pr
Contact
t.fuchs-buder@chru-nancy.fr
Thomas FUCHS-BUDER, Pr
principal investigator · CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation - VANDOEUVRE LES NANCY - FRANCE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Rocuronium

Other studies from this sponsor

Central Hospital, Nancy, France →

Start the discussion