NCT03052894

Validation of a Muscle Relaxation Monitor

Validation of a Device to Monitor Muscle Relaxation During Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Richard H Epstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DEVICE	Hydraulic Monitoring Device	The hydraulic monitoring device externally measures the pressure associated with thumb strength applied to the device to determine the depth of neuromuscular blockade during general anesthesia. This will be compared to measurements using a current monitoring device in the same patient.
DEVICE	Standard EMG Monitoring Device	Standard and in current usage, the electromyographic monitoring (EMG) device externally measures the action potential of the muscles of the thumb to determine the depth of neuromuscular blockade during general anesthesia. This will be used as the clinical monitoring device and as a comparator.

Timeline

• Start date: 2018-12-31
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-02-14
• Last updated: 2019-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study