[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658465":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":48,"collaborators":13,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":13,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":13,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":83,"whyStopped":13,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Peak Increase in Perfusion Index","Perfusion index (PI) is monitored continuously using a pulse oximeter probe placed on the middle finger of the right hand. PI reflects the ratio of pulsatile to non-pulsatile infrared light absorption (AC\u002FDC x 100). Baseline PI is calculated as the mean of three consecutive stable readings obtained prior to caudal block placement. The primary outcome is the maximum increase in PI from baseline (peak PI minus baseline PI) observed during surgery and the recovery stay.","Up to 4 hours",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Group C: Caudal Dexmedetomidine","ACTIVE_COMPARATOR","Participants receive a caudal block containing 0.25% levobupivacaine (1 mL\u002Fkg) combined with dexmedetomidine (1 µg\u002Fkg) injected over 60 seconds, accompanied by a simultaneous intravenous placebo infusion of 20 mL normal saline administered over 10 minutes.",[31],"Drug: Caudal Dexmedetomidine",{"label":33,"type":34,"description":35,"interventionNames":36},"Group I: Intravenous Dexmedetomidine","EXPERIMENTAL","Participants receive a caudal block containing 0.25% levobupivacaine (1 mL\u002Fkg) alone injected over 60 seconds, accompanied by a simultaneous intravenous infusion of dexmedetomidine (1 µg\u002Fkg) diluted in 20 mL normal saline administered over 10 minutes.",[37],"Drug: Intravenous Dexmedetomidine",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"DRUG","Caudal Dexmedetomidine","Dexmedetomidine (1 µg\u002Fkg) combined with 0.25% levobupivacaine (total volume 1 mL\u002Fkg) administered into the caudal epidural space over 60 seconds under general anesthesia, along with a concurrent 10-minute IV placebo infusion of 20 mL normal saline.",[27],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"Intravenous Dexmedetomidine","Dexmedetomidine (1 µg\u002Fkg) diluted in 20 mL normal saline administered as an intravenous infusion over 10 minutes, along with a concurrent caudal injection of 0.25% levobupivacaine (1 mL\u002Fkg) administered over 60 seconds under general anesthesia.",[33],{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mohamed Gamal El-Deen Mohamed Sallam","Resident","100658465","phase-4-effect-of-intravenous-versus-caudal-dexmedetomidine-on-perfusion-index-and-hemodynamic-responses-in-children-undergoing-infraumbilical-surgery-100658465",false,"NCT07852039","Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery","Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery: A Randomized Double-Blind Controlled Study","Inclusion Criteria:\n\n* Pediatric patients aged 1 to 7 years.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Scheduled for elective infraumbilical surgery.\n* Anticipated duration of surgery less than 120 minutes.\n* Written informed consent obtained from parents or legal guardians.\n\nExclusion Criteria:\n\n* Coagulopathy or bleeding disorders.\n* Pre-existing local infection at the caudal injection site.\n* Known congenital heart disease.\n* Neurological or neuromuscular disorders.\n* Known allergy or hypersensitivity to dexmedetomidine, local anesthetics, or any study medication.\n* Significant developmental delay affecting pain assessment.\n* Failed caudal block.\n* Parental or guardian refusal to participate.","ALL","1 Year","7 Years",{"count":63,"type":64},100,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","Caudal anesthesia is widely used to provide pain relief for children undergoing surgery below the navel (infraumbilical surgery). Dexmedetomidine is a medication commonly added to local anesthetics to enhance pain control and reduce stress responses during surgery. It can be given directly into the caudal space or through an intravenous (IV) line into the bloodstream, but it remains unclear which route provides better blood flow regulation and vital sign stability.\n\nThis study aims to compare the effects of caudal versus intravenous dexmedetomidine on peripheral blood flow, measured non-invasively using the Perfusion Index (PI), as well as heart rate and blood pressure in pediatric patients.\n\nA total of 100 children aged 1 to 7 years undergoing elective infraumbilical surgery will be randomly assigned to one of two groups:\n\n* Group C (Caudal Group): Receives dexmedetomidine added to the caudal local anesthetic (levobupivacaine) alongside an IV saline placebo infusion.\n* Group I (Intravenous Group): Receives the caudal local anesthetic alone alongside an IV infusion containing dexmedetomidine.\n\nNeither the parents nor the healthcare team will know which study drug regimen the child receives. Investigators will record changes in the Perfusion Index, monitor heart rate and blood pressure throughout surgery and recovery, and evaluate postoperative pain scores and recovery room discharge times.",[70,71,72,73],"Postoperative Pain","Caudal Anesthesia","Peripheral Perfusion","Pediatric Surgery",[75,76,77,78,79,80,81,82],"Dexmedetomidine","Perfusion Index","Caudal Block","Levobupivacaine","Hemodynamics","Infraumbilical Surgery","Pediatric Anesthesia","Postoperative Analgesia","NOT_YET_RECRUITING","2026-09-25",{"date":86,"type":87},"2026-10-01","ACTUAL",{"date":89,"type":64},"2026-10",{"date":91,"type":64},"2027-11",{"name":5,"class":6}]