NCT04352140

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 17, 2023

Completed
Last Updated

February 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

April 16, 2020

Results QC Date

January 24, 2023

Last Update Submit

January 24, 2023

Conditions

Residual Neuromuscular Blockade

Keywords

Neuromuscular BlockadeTetragraphAMGEMG

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of Residual Neuromuscular Blockade

    Up to 1 hour postoperatively

Study Arms (2)

Dominant hand

EXPERIMENTAL

Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand

Device: TetragraphDevice: ToFscan

Non-dominant hand

EXPERIMENTAL

Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand

Device: TetragraphDevice: ToFscan

Interventions

TetragraphDEVICE

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.

Dominant handNon-dominant hand
ToFscanDEVICE

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

Dominant handNon-dominant hand

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Université de Lorraine, CHU de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

University of Debrecen

Debrecen, 4031, Hungary

Location

Related Links

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
J. Ross Renew, M.D.
Organization
Mayo Clinic
Renew.J@mayo.edu
904-956-3325

Study Officials

  • J.Ross Renew, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

August 18, 2020

Primary Completion

February 14, 2022

Study Completion

February 14, 2022

Last Updated

February 17, 2023

Results First Posted

February 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)FR(1)US(1)