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Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve

Not Applicable
Completed
Conditions
Residual Neuromuscular Blockade
Interventions
Device: TetraGraph
Registration Number
NCT04352127
Lead Sponsor
Mayo Clinic
Brief Summary

Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
55
Inclusion Criteria
  • Age > or = 18 years old
  • Patients willing to participate and provide an informed consent
  • Patients undergoing an elective 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
Non-dominant handTetraGraphSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand
Dominant handTetraGraphSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand
Primary Outcome Measures
NameTimeMethod
Subjective Evaluation to Neurostimulationup to 1 hour postoperatively

The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.

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

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

Trial Locations

Locations (1)

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

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