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Regional Anesthesia EMG Study

NCT06287151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Surgery

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Grant Heydinger, MD · Nationwide Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287151 on ClinicalTrials.gov