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