NCT06287151

Regional Anesthesia EMG Study

Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies.

Detailed description

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. The hypothesis is that EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.

Conditions

• Surgery

Interventions

Type	Name	Description
DEVICE	BlockSynop surface electromyography device	The EMG monitor uses non-invasive surface electrodes that measures electrical activity in response to muscle stimulation. After all electrodes have been placed on the patient, the electrodes will be connected to a prototype non-significant risk device (NSR) BlockSynop surface electromyography device and monitoring of sEMG signal will begin. The device is a non-invasive and non-significant risk device.
DRUG	Clonidine	Clonidine is an alpha-2-agonist which is commonly used as an adjunct in spinal anesthesia and caudal anesthesia to improve both the quality and duration of blockade.
DRUG	Sevoflurane	5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.

Timeline

• Start date: 2023-08-09
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-02-29
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study