Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function

• Conditions: Neuromuscular Blockade

• Registration Number: NCT04816539
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Assess the values of train-of-four ratios with the TetraGraph and thoses obtained with the TOFscan during recovery of neuromusculat function in surgical patients who have been administred rocuronium.

Primary outcome : value of TOFratio with the TetraGraph when TOFratio of TOFscan is greater than or equal to 90% Pilot study : no hypothesis

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-25
• Last Update Posted: 2021-03-25
• Study Start: 2021-04-15
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age greater than or equal to 18 years old
• patients willing to participate and provide an informed consent
• elective surgical procedures, without emergency, administration of rocuronium for neuromuscular blockade, and recovery of complete neuromuscular function at the end of the surgery

Exclusion Criteria

• patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or similar wrist injury
• patients with systemic neuromuscular diseases such as myasthenia gravis
• renal insufficiency or renal failure
• significant liver disease
• patients having surgery that would involve prepping the arm into the sterile field
• allergy to rocuronium

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Train-of-four ratios	baseline (J0)	Value of TOFratio with TetraGraph when TOFratio with TOFscan is greater than or equal to 90% (first value of three greater than or equal to 90%)

Secondary Outcome Measures

Name	Time	Method
Train-of-four ratios	baseline (J0)	Value of TOFratio with TOFscan when TOFratio with TetraGraph is greater than or equal to 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and eventually 100%
Train-of-four count	baseline (J0)	Time to recover one, two, three and four responses from TOFcount with TOFscan and TetraGraph

Trial Locations

Locations (1)

Chu Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France