Regional Anesthesia EMG Study

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287151
• Other study ID #: STUDY00002844
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Catherine Roth
• Phone: 614-722-2997
• Email: catherine.roth[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.	Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.	Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Primary	Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .	Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.	Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Primary	Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.	Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.	Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Primary	Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.	Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.	Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Secondary	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.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Secondary	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.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Secondary	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.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Secondary	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.	Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.	Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.
Secondary	Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.	Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.	Intraoperative time frame. Timeframe being day of surgery.