nctId: NCT06287151 id: STUDY00002844 briefTitle: Regional Anesthesia EMG Study overallStatus: RECRUITING date: 2023-08-09 date: 2024-12 date: 2024-12 date: 2024-02-29 date: 2024-02-29 name: Nationwide Children's Hospital class: OTHER briefSummary: 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. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Choice of group will be made by attending anesthesiologist based on clinical judgement. primaryPurpose: OTHER masking: SINGLE maskingDescription: Only the individuals performing data analysis will be blinded to type of anesthetic technique performed. whoMasked: OUTCOMES_ASSESSOR count: 124 type: ESTIMATED name: BlockSynop surface electromyography device name: Clonidine name: Sevoflurane measure: Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. . measure: Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. measure: 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. measure: 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. measure: 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. measure: 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. measure: Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. sex: ALL minimumAge: 0 Years maximumAge: 5 Years stdAges: CHILD facility: Nationwide Children's Hospital status: RECRUITING city: Columbus state: Ohio zip: 43205 country: United States name: Catherine Roth role: CONTACT phone: 614-722-2997 email: catherine.roth@nationwidechildrens.org name: Grant Heydinger, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False