Surgery
Conditions
Brief 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.
Detailed 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.
Interventions
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.
DRUGClonidine
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.
DRUGSevoflurane
5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Only the individuals performing data analysis will be blinded to type of anesthetic technique performed.
Intervention model description
Choice of group will be made by attending anesthesiologist based on clinical judgement.
Eligibility
Sex/Gender
ALL
Age
0 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. | 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. |
| Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. . | 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. |
| Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. | 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. |
| Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. | Intraoperative time frame. Timeframe being day of surgery. | Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGrant Heydinger, MD
Nationwide Children's Hospital
Outcome results
None listed