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

Not Applicable

Completed

• Conditions: Neuromuscular Residual Curarization
• Interventions: Device: WiTOF; Device: TOFscan

• Registration Number: NCT05231525
• Lead Sponsor: Poitiers University Hospital

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.

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-09
• Study Start: 2022-03-09
• Primary Completion: 2022-06-20
• Study Completion: 2022-09-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WiTOF	WiTOF	-
TOFscan	TOFscan	-

Primary Outcome Measures

Name	Time	Method
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.	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 Outcome Measures

Name	Time	Method
Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor	During the whole period of the surgical operation maximum 8 hours	Assess what could perturbate the data collection on the wireless monitor
Evaluate the performance of the monitors for the follow up of neuromuscular recovery	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)

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France