Using EMG monitoring to assess anesthesia in young children during surgery
Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)
This study is testing if a special monitoring technique can help doctors better understand how anesthesia works in young children during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 0 Years to 5 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06287151 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of non-invasive EMG monitoring to objectively characterize neuraxial anesthesia in pediatric patients undergoing various surgical procedures. It aims to measure the effects of adjunctive intrathecal clonidine on spinal and caudal blockade and to quantify the impact of sevoflurane on muscle tone through EMG changes. The study will generate pilot data to inform future research on these topics, focusing on children aged 5 years or younger. The hypothesis is that EMG can effectively measure aspects of neuraxial blockade such as onset, resolution, density, and dermatomal level.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 5 years or younger undergoing specific surgical procedures such as circumcision, hernia repair, or other urological surgeries.
Not a fit: Patients with systemic infections, spine or CNS abnormalities, or those with medication allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anesthesia management in pediatric surgeries.
How similar studies have performed: While the use of EMG monitoring in anesthesia is a growing field, this specific approach in pediatric patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Group 1 (GA + penile block): age 5 years or below getting: circumcision or circumcision revision * Group 2-5 (SA or GA + CA): age 5 years or below getting: penile or scrotal surgery, inguinal hernia repair, Achilles tendon lengthening, other applicable urological procedures * Group 6 (GA only): age 5 years or below getting: operative dentistry, urological or ENT procedures Exclusion Criteria: * parent refusal * systemic infection * spine or CNS abnormalities * medication allergy * adhesive allergy
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Grant Heydinger, MD — Nationwide Children's Hospital
- Study coordinator: Catherine Roth
- Email: catherine.roth@nationwidechildrens.org
- Phone: 614-722-2997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.