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

Neuromuscular Blockade Clinical Trial

— DECURAR-EMG  

Official title:

Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function : a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04816539
• Other study ID #: 2020-A03054-35
• Status: Not yet recruiting
• Start date: April 15, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: March 2021
• Source: Central Hospital, Nancy, France
• Contact: Claude Meistelman
• Phone: 0383153464
• Email: c.meistelman[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• TetraGraph
Use of two monitoring devices of neuromuscular function during surgery

Locations

Country	Name	City	State
France	Chu Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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