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Completed

NCT Number: NCT06287151

Regional Anesthesia EMG Study

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.

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Key information

Conditions

Surgery

Age range

0 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BlockSynop surface electromyography device

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.

Clonidine

Drug

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.

Sevoflurane

Drug

5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.

Primary outcomes

  1. Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.

    Time frame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.

    Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.

  2. Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .

    Time frame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.

    Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.

  3. Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.

    Time frame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.

    Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.

  4. Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.

    Time frame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.

    Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.

Secondary outcomes

  1. Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude.

    Time frame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.

    Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.

  2. Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude.

    Time frame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.

    Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.

  3. Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude.

    Time frame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.

    Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.

  4. Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude.

    Time frame: Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.

    Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.

  5. Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.

    Time frame: Intraoperative time frame. Timeframe being day of surgery.

    Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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