Validation of a Muscle Relaxation Monitor

Richard H Epstein

Status: Terminated

Conditions: Neuromuscular Blockade

Treatments: Device: Hydraulic Monitoring Device; Device: Standard EMG Monitoring Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03052894

20161018

Details and patient eligibility

About

The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.

Full description

Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb ("twitch") following delivery of a series of the "train-of-four".

Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.

The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Age >18
2. Surgery is elective
3. Subject has been NPO for fluids for >2 hours and for solids >8 hours
4. General anesthesia with tracheal intubation is required
5. Mask ventilation is expected to be without difficulty
6. Subject voluntarily consents in writing to the protocol
7. ASA Physical Status 1-III (healthy individuals, those with mild comorbid conditions, or those with more serious co-morbid conditions that are well controlled)

Exclusion Criteria:

1. Lack of ability to provide written, informed consent
2. Airway examination indicates a likelihood of difficult mask ventilation
3. Symptoms of active reflux at the time of induction, at risk of having food in their stomach at the time of induction, expected abnormal response to non-depolarizing neuromuscular blockers
4. Age ≤18 years
5. Pregnant women
6. Presence of carpal tunnel syndrome
7. Prisoners
8. General anesthesia not being provided
9. Tracheal intubation will not be performed
10. Anticipated length of surgery <60 minutes
11. Emergent or urgent surgery
12. Disease that might alter the normal neuromuscular response to electrical stimulation (e.g., muscular dystrophies, myasthenia gravis, quadriplegia).
13. ASA Physical Status IV or V (individuals with major comorbid conditions that are a constant source of risk to health)

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Hydraulic Monitoring Device

Experimental group

Description:

Monitoring device to be compared to electromyographic (EMG) device in the same patient; measures depth of neuromuscular blockade during general anesthesia based on the pressure exerted by the muscles of the thumb.

Treatment:

Device: Hydraulic Monitoring Device

Standard EMG Monitoring Device

Active Comparator group

Description:

Currently used standard monitoring device; measures depth of neuromuscular blockade during general anesthesia based on the action potential of the muscles of the thumb.

Treatment:

Device: Standard EMG Monitoring Device