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Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting

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Mayo Clinic

Status

Completed

Conditions

Residual Neuromuscular Blockade

Treatments

Device: ToFscan
Device: Tetragraph

Study type

Interventional

Funder types

Other

Identifiers

NCT04352140
20-000629

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Dominant hand
Experimental group
Description:
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand
Treatment:
Device: Tetragraph
Device: ToFscan
Non-dominant hand
Experimental group
Description:
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
Treatment:
Device: Tetragraph
Device: ToFscan

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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