Trial Outcomes & Findings for Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve (NCT NCT04352127)

NCT ID: NCT04352127

Last Updated: 2022-11-10

Results Overview

The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: up to 1 hour postoperatively
• Results posted on: 2022-11-10

Participant Flow

Participant milestones

Measure	Dominant Hand 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.	Non-dominant Hand 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.
Overall Study STARTED	29	26
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Dominant Hand 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.	Non-dominant Hand 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.
Overall Study Unable to obtain readings	4	1

Baseline Characteristics

Baseline characteristics were not collected for the Anesthesia providers

Baseline characteristics by cohort

Measure	Dominant Hand n=25 Participants 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.	Non-dominant Hand n=25 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 13.1 • n=25 Participants • Baseline characteristics were not collected for the Anesthesia providers	57.9 years STANDARD_DEVIATION 16.2 • n=25 Participants • Baseline characteristics were not collected for the Anesthesia providers	57.9 years STANDARD_DEVIATION 14.7 • n=50 Participants • Baseline characteristics were not collected for the Anesthesia providers
Sex: Female, Male Female	16 Participants n=25 Participants • Baseline characteristics were not collected for the Anesthesia providers	17 Participants n=25 Participants • Baseline characteristics were not collected for the Anesthesia providers	33 Participants n=50 Participants • Baseline characteristics were not collected for the Anesthesia providers
Sex: Female, Male Male	9 Participants n=25 Participants • Baseline characteristics were not collected for the Anesthesia providers	8 Participants n=25 Participants • Baseline characteristics were not collected for the Anesthesia providers	17 Participants n=50 Participants • Baseline characteristics were not collected for the Anesthesia providers
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants

PRIMARY outcome

Timeframe: up to 1 hour postoperatively

The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.

Outcome measures

Measure	Dominant Hand n=25 Participants 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.	Non-dominant Hand n=25 Participants 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.
Subjective Evaluation to Neurostimulation	48.2 percentage of evaluations	44.8 percentage of evaluations

SECONDARY outcome

Timeframe: Up to 1 hour postoperatively

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

Outcome measures

Measure	Dominant Hand n=25 Participants 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.	Non-dominant Hand n=25 Participants 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.
Incidence of Residual Neuromuscular Blockade	1 Participants	0 Participants

Adverse Events

Dominant Hand

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-dominant Hand

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J. Ross Renew, M.D.

Mayo Clinic

Phone: 904-956-3328

Email: Renew.J@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place