Trial Outcomes & Findings for Comparison Neuromuscular Blockade Monitors (NCT NCT05006807)

Results Overview

Determine evoked thumb twitch response to ulnar nerve train-of-four stimulation then determine the ratio of the amplitude of the fourth twitch divided by the first twitch, referred to as the train-of-four ratio. The train-of-four ratio is expected to be 1.0 in the absence of neuromuscular blocking drugs. The range of possible train-of-four ratios is 0-1.6. Results that deviate from a train-of-four ratio of 1.0 represent inaccuracy of the measurement.

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

Procedure (from the induction of anesthesia until emergence of anesthesia)

Results posted on

2026-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Accuracy and Precision of 3 Acceleromyographs, Three Electromyographs and a Mechanomyograph The accuracy and precision of train-of-four ratio measurements of three electromyography monitors and three acceleromyography monitors were determined in 28 patients having surgery under general anesthesia without neuromuscular blocking drugs, using mechanomyography as a "gold standard" reference.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Accuracy and Precision of 3 Acceleromyographs, Three Electromyographs and a Mechanomyograph n=28 Participants The accuracy and precision of train-of-four ratio measurements of three electromyography monitors and three acceleromyography monitors were determined in 28 patients having surgery under general anesthesia without neuromuscular blocking drugs, using mechanomyography as a "gold standard" reference.
Age, Continuous	56.0 years STANDARD_DEVIATION 17.9 • n=28 Participants
Sex: Female, Male Female	14 Participants n=28 Participants
Sex: Female, Male Male	14 Participants n=28 Participants
Region of Enrollment United States	28 participants n=28 Participants
General anesthesia without neuromuscular blocking drugs	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Procedure (from the induction of anesthesia until emergence of anesthesia)

Population: Not all monitors were testing in all subjects, therefore the analysis population is less than 28 for each monitor.

Determine evoked thumb twitch response to ulnar nerve train-of-four stimulation then determine the ratio of the amplitude of the fourth twitch divided by the first twitch, referred to as the train-of-four ratio. The train-of-four ratio is expected to be 1.0 in the absence of neuromuscular blocking drugs. The range of possible train-of-four ratios is 0-1.6. Results that deviate from a train-of-four ratio of 1.0 represent inaccuracy of the measurement.

Outcome measures

Outcome measures
Measure	Accuracy and Precision of 3 Acceleromyographs, Three Electromyographs and a Mechanomyograph n=28 Participants The accuracy and precision of train-of-four ratio measurements of three electromyography monitors and three acceleromyography monitors were determined in 28 patients having surgery under general anesthesia without neuromuscular blocking drugs, using mechanomyography as a "gold standard" reference.
Train-of-four Ratio ToFscan AMG	1.13 units on a scale Interval 0.95 to 1.32
Train-of-four Ratio Stimpod AMG	1.10 units on a scale Interval 1.07 to 1.14
Train-of-four Ratio Philips AMG	1.11 units on a scale Interval 1.02 to 1.2
Train-of-four Ratio TwitchView EMG	0.99 units on a scale Interval 0.98 to 1.0
Train-of-four Ratio Stimpod EMG	1.01 units on a scale Interval 1.0 to 1.02
Train-of-four Ratio Tetragraph EMG	1.01 units on a scale Interval 1.0 to 1.02
Train-of-four Ratio Mechanomyography	0.99 units on a scale Interval 0.98 to 1.0

Adverse Events

Accuracy and Precision of 3 Acceleromyographs, Three Electromyographs and a Mechanomyograph

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

Andrew Bowdle MD, PhD, FASE

University of Washington

Phone: 2069790477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place