Completed

NCT Number: NCT05231525

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

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.

Completed

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Key information

Conditions

Neuromuscular Residual Curarization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, 86021, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WiTOF

Device

Data collection on the WiTOF monitor

TOFscan

Device

Data collection on the TOFscan monitor

Primary outcomes

Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.

Time frame: During the whole period of the surgical operation maximum 8 hours

Comparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan

Secondary outcomes

Evaluate the performance of the monitors for the follow up of neuromuscular recovery

Time frame: During the whole period of the surgical operation maximum 8 hours

Comparison 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 monitor

Time frame: During the whole period of the surgical operation maximum 8 hours

Assess what could perturbate the data collection on the wireless monitor

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Feb 9, 2022
Registry last updated: Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.