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Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Primary Purpose

Residual Neuromuscular Blockade

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

TetraGraph (TG)

ToFscan (TS)

About this trial

This is an interventional supportive care trial for Residual Neuromuscular Blockade focused on measuring Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

Patients with unilateral 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.

Sites / Locations

Mayo Clinic in Florida
NorthShore University HealthSystem
University of Debrecen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tetragraph (TG)

ToFscan (TS)

Arm Description

TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand

ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand

Outcomes

Primary Outcome Measures

Mean Train-of-Four Ratios (TOFR's)

Train-of-four ratios is the ratio of the fourth muscle response to the first one.

Secondary Outcome Measures

Full Information

NCT ID

NCT03920670

First Posted

February 13, 2019

Last Updated

March 31, 2021

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03920670

Brief Title

Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Official Title

Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 28, 2019 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Residual Neuromuscular Blockade

Keywords

Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tetragraph (TG)

Arm Type

Experimental

Arm Description

TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand

Arm Title

ToFscan (TS)

Arm Type

Active Comparator

Arm Description

ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand

Intervention Type

Device

Intervention Name(s)

TetraGraph (TG)

Intervention Description

TetraGraph device is a neuromuscular transmission monitor capable of estimating 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 percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

Intervention Type

Device

Intervention Name(s)

ToFscan (TS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Train-of-Four Ratios (TOFR's)

Description

Train-of-four ratios is the ratio of the fourth muscle response to the first one.

Time Frame

baseline, after 5 minutes, after + 10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 non-depolarizing NMBA agents administered intraoperatively. Exclusion Criteria Patients with unilateral 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J Ross Renew, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

University of Debrecen

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

12. IPD Sharing Statement

Citations:

PubMed Identifier

30130260

Citation

Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.

Results Reference

background

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

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