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COMPLETED
NCT06287151
NA

Regional Anesthesia EMG Study

Sponsor: Nationwide Children's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-08-09

Completion Date

2025-02-28

Last Updated

2026-08-06

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States