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Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting

Not Applicable
Completed
Conditions
Residual Neuromuscular Blockade
Interventions
Device: Tetragraph
Device: ToFscan
Registration Number
NCT04352140
Lead Sponsor
Mayo Clinic
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dominant handTetragraphSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand
Dominant handToFscanSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand
Non-dominant handTetragraphSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
Non-dominant handToFscanSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
Primary Outcome Measures
NameTimeMethod
Accuracy of Values Between Tetragraph and ToFscanUp to 1 hour postoperatively

The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan

Secondary Outcome Measures
NameTimeMethod
Incidence of Residual Neuromuscular BlockadeUp to 1 hour postoperatively

Number of patients with train of four ratio \< 0.9 after administration of reversal agent.

Trial Locations

Locations (3)

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

Université de Lorraine, CHU de Brabois

🇫🇷

Vandœuvre-lès-Nancy, France

University of Debrecen

🇭🇺

Debrecen, Hungary

Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
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