Back to resultsElectromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
Primary Purpose
Residual Neuromuscular Blockade
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tetragraph
ToFscan
Sponsored by
About this trial
This is an interventional other trial for Residual Neuromuscular Blockade focused on measuring Neuromuscular Blockade, Tetragraph, AMG, EMG
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Florida
- Université de Lorraine, CHU de Brabois
- University of Debrecen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dominant hand
Non-dominant hand
Arm 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
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of Residual Neuromuscular Blockade
Number of patients with train of four ratio < 0.9 after administration of reversal agent.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04352140
Brief Title
Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
Official Title
Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
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, Tetragraph, AMG, EMG
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dominant hand
Arm Type
Experimental
Arm 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
Arm Title
Non-dominant hand
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Tetragraph
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ToFscan
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
Accuracy of Values Between Tetragraph and ToFscan
Description
The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan
Time Frame
Up to 1 hour postoperatively
Secondary Outcome Measure Information:
Title
Incidence of Residual Neuromuscular Blockade
Description
Number of patients with train of four ratio < 0.9 after administration of reversal agent.
Time Frame
Up to 1 hour postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Université de Lorraine, CHU de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
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