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

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ClinicalTrials.gov Identifier: NCT03920670
Recruitment Status : Completed
First Posted : April 19, 2019
Results First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
J. Ross Renew, M.D., Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Residual Neuromuscular Blockade
Interventions Device: TetraGraph (TG)
Device: ToFscan (TS)
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
Hide Arm/Group Description

TetraGraph was placed on dominant hand, ToFscan (TS) was placed on non-dominant hand

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 was measured.

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 was measured.

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

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 was measured.

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 was measured.

Period Title: Overall Study
Started 60 60
Completed 57 58
Not Completed 3 2
Reason Not Completed
Protocol Violation             2             2
Adverse Event             1             0
Arm/Group Title Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand Total
Hide Arm/Group Description

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

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 was measured.

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 was measured.

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

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 was measured.

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 was measured.

Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
55.5  (15.2) 55.6  (15.1) 55.6  (15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
36
  60.0%
38
  63.3%
74
  61.7%
Male
24
  40.0%
22
  36.7%
46
  38.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Mean Train-of-Four Ratios (TOFR's)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Dominant arm Train-of-Four Ratios collected for analysis
Arm/Group Title Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
Hide Arm/Group Description:

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

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 was measured.

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 was measured.

Dominant arm Train-of-Four Ratios collected for analysis

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

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 was measured.

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 was measured.

Dominant arm Train-of-Four Ratios collected for analysis

Overall Number of Participants Analyzed 57 58
Mean (Standard Deviation)
Unit of Measure: Ratio
baseline 0.97  (0.18) 0.94  (0.13)
after 5 minutes 0.96  (0.20) 0.95  (0.12)
after + 10 minutes 0.99  (.014) 0.94  (0.12)
Time Frame Adverse events were collected from baseline to end of scan, for a total of approximately 10 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
Hide Arm/Group Description

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

TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

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

TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

All-Cause Mortality
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
Affected / at Risk (%) Affected / at Risk (%)
Total   0/115 (0.00%)   0/115 (0.00%) 
Hide Serious Adverse Events
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
Affected / at Risk (%) Affected / at Risk (%)
Total   0/115 (0.00%)   0/115 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
Affected / at Risk (%) Affected / at Risk (%)
Total   0/115 (0.00%)   0/115 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: J. Ross Renew, M.D.
Organization: Mayo Clinic
Phone: 904-956-3328
EMail: Renew.J@mayo.edu
Layout table for additonal information
Responsible Party: J. Ross Renew, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT03920670    
Other Study ID Numbers: 18-011298
First Submitted: February 13, 2019
First Posted: April 19, 2019
Results First Submitted: March 1, 2021
Results First Posted: April 29, 2021
Last Update Posted: April 29, 2021