Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT04352127
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.

Condition or Disease	Intervention/Treatment	Phase
Residual Neuromuscular Blockade	Device: TetraGraph	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Other
• Official Title: Comparison of Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve
• Actual Study Start Date: Aug 18, 2020
• Actual Primary Completion Date: Jun 29, 2021
• Actual Study Completion Date: Jun 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dominant hand Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand	Device: TetraGraph; 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.
Experimental: Non-dominant hand Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand	Device: TetraGraph; 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.

Outcome Measures

Primary Outcome Measures

1. Subjective Response to Neurostimulation [up to 1 hour postoperatively]

   The percentage of visual provider evaluations that overestimated the response of the adductor pollics musle following train-of-four stimulation of the ulnar nerve. Visual count observation relied on the providers count of muscle twitches.

Secondary Outcome Measures

1. Incidence of Residual Neuromuscular Blockade [Up to 1 hour postoperatively]

   Number of subjects with train of four ratio < 0.9 after administration of reversal agent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: J.Ross Renew, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 13, 2021

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: J. Ross Renew, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04352127
• Other Study ID Numbers: 20-000619
• First Posted: Apr 20, 2020
• Last Update Posted: Jun 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by J. Ross Renew, M.D., Principal Investigator, Mayo Clinic: Neuromuscular Blockade; Tetragraph; AMG; EMG
• Additional relevant MeSH terms: Delayed Emergence from Anesthesia

Study Results

Participant Flow

Arm/Group Title	Dominant Hand	Non-dominant Hand	Anesthesia Providers
Arm/Group Description	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand TetraGraph: 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.	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand TetraGraph: 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.	Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
Period Title: Overall Study
STARTED	29	26	50
COMPLETED	25	25	50
NOT COMPLETED	4	1	0

Baseline Characteristics

Arm/Group Title	Dominant Hand	Non-dominant Hand	Anesthesia Providers	Total
Arm/Group Description	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand TetraGraph: 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.	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand TetraGraph: 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.	Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage	Total of all reporting groups
Overall Participants	25	25	0	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.9 (13.1)	57.9 (16.2)	57.9 (14.7)
Sex: Female, Male (Count of Participants)
Female	16 64%	17 68%	33 Infinity
Male	9 36%	8 32%	17 Infinity
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	100 Infinity

Outcome Measures

1. Primary Outcome

Title	Subjective Response to Neurostimulation
Description	The percentage of visual provider evaluations that overestimated the response of the adductor pollics musle following train-of-four stimulation of the ulnar nerve. Visual count observation relied on the providers count of muscle twitches.
Time Frame	up to 1 hour postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Providers
Arm/Group Description	Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
Measure Participants	50
Number [percentage of evaluations]	46.5

2. Secondary Outcome

Title	Incidence of Residual Neuromuscular Blockade
Description	Number of subjects with train of four ratio < 0.9 after administration of reversal agent.
Time Frame	Up to 1 hour postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dominant Hand	Non-dominant Hand
Arm/Group Description	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand TetraGraph: 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.	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand TetraGraph: 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.
Measure Participants	25	25
Count of Participants [Participants]	1 4%	0 0%

Adverse Events

Time Frame	Adverse Events will be collected from baseline to end of study, approximately 1 hour
Arm/Group Title	Dominant Hand		Non-dominant Hand		Anesthesia Providers
Arm/Group Description	Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand TetraGraph: 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.		Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand TetraGraph: 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.		Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
All Cause Mortality
	Dominant Hand		Non-dominant Hand		Anesthesia Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/50 (0%)
Serious Adverse Events
	Dominant Hand		Non-dominant Hand		Anesthesia Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Dominant Hand		Non-dominant Hand		Anesthesia Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.