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Comparison of the TOFScan and the WiTOF During Recovery of Neuromuscular Function

Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05231525
Enrollment
80
Registered
2022-02-09
Start date
2022-03-09
Completion date
2022-09-20
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Residual Curarization

Brief summary

The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.

Detailed description

The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.

Interventions

DEVICEWiTOF

Data collection on the WiTOF monitor

DEVICETOFscan

Data collection on the TOFscan monitor

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* All programmed surgery with intraveinous injection of ATRACURIUM * American society of anesthesiology patient score of I, II or III * Patient being free of tutorship or curatorship * Acceptance of the patient after clear and loyal information

Exclusion criteria

* Surgery without access simultaneously to the two arms * Emergency surgery * Rapid sequence induction * Usage of an other curare than ATRACURIUM * Contraindication on ATRACURIUM usage * Patient with pace maker * Patient with Arné score \> or = to 11 * Patient without social security coverage * Pregnant of breastfeeding women * Patient under social protection

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.During the whole period of the surgical operation maximum 8 hoursComparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan

Secondary

MeasureTime frameDescription
Evaluate the performance of the monitors for the follow up of neuromuscular recoveryDuring the whole period of the surgical operation maximum 8 hoursComparison of neuromuscular blockade parameters obtained with the WiTOF and the TOFScan (TOF, PTC, T4/1R)
Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitorDuring the whole period of the surgical operation maximum 8 hoursAssess what could perturbate the data collection on the wireless monitor

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026