Regional Anesthesia EMG Study
- Conditions
- Surgery
- Interventions
- Registration Number
- NCT06287151
- Lead Sponsor
- Nationwide Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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
- parent refusal
- systemic infection
- spine or CNS abnormalities
- medication allergy
- adhesive allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spinal Anesthesia without Clonidine BlockSynop surface electromyography device Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine General Anesthesia with Caudal Anesthesia with Clonidine BlockSynop surface electromyography device Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population. General Anesthesia with Caudal Anesthesia without Clonidine BlockSynop surface electromyography device Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg General Anesthesia with Caudal Anesthesia without Clonidine Sevoflurane Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg General Anesthesia only BlockSynop surface electromyography device GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients. General Anesthesia with Penile Block BlockSynop surface electromyography device Penile block: prior to the start of surgery 0.5mg/kg of 0.25% bupivacaine w/o epinephrine will be administered GA : Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients. Spinal Anesthesia with Clonidine BlockSynop surface electromyography device Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population. Spinal Anesthesia with Clonidine Clonidine Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population. General Anesthesia with Caudal Anesthesia with Clonidine Clonidine Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population. General Anesthesia with Caudal Anesthesia with Clonidine Sevoflurane Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population. General Anesthesia only Sevoflurane GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
- Primary Outcome Measures
Name Time Method 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 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 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 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States