Validation of a Muscle Relaxation Monitor

Not Applicable

Terminated

• Conditions: Neuromuscular Blockade
• Interventions: Device: Hydraulic Monitoring Device; Device: Standard EMG Monitoring Device

• Registration Number: NCT03052894
• Lead Sponsor: Richard H Epstein

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-14
• Study Start: 2018-12-31
• Status Verified: 2019-12
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydraulic Monitoring Device	Hydraulic Monitoring Device	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.
Standard EMG Monitoring Device	Standard EMG Monitoring Device	Currently used standard monitoring device; measures depth of neuromuscular blockade during general anesthesia based on the action potential of the muscles of the thumb.

Primary Outcome Measures

Name	Time	Method
Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis	12 months	To determine the accuracy (bias and precision) of a the monitoring device as compared to the electromyographic (EMG) monitor in measuring the extent of neuromuscular blockade in subjects undergoing general anesthesia.

Trial Locations

Locations (1)

Department of Anesthesiology at University of Miami Hospital; 🇺🇸 Miami, Florida, United States