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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04352140
Other study ID # 20-000629
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2020
Est. completion date February 14, 2022

Study information

Verified date January 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 14, 2022
Est. primary completion date February 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > or = 18 years old - Patients willing to participate and provide an informed consent - Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively. Exclusion Criteria: - Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury. - Patients with systemic neuromuscular diseases such as myasthenia gravis - Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease. - Patients having surgery that would involve prepping the arm or leg into the sterile field

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Tetragraph
FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
ToFscan
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured

Locations

Country Name City State
France Université de Lorraine, CHU de Brabois VandÅ“uvre-lès-Nancy
Hungary University of Debrecen Debrecen
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  France,  Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of Values Between Tetragraph and ToFscan The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan Up to 1 hour postoperatively
Secondary Incidence of Residual Neuromuscular Blockade Number of patients with train of four ratio < 0.9 after administration of reversal agent. Up to 1 hour postoperatively
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Withdrawn NCT03574337 - Residual Neuromuscular Blockade in Cardiac Surgery Patients Phase 4

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