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Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery

StatusNot Yet Recruiting
PhasePhase 4
Started2026-10
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1,604 trials monitored
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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. This 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. A total of 100 children aged 1 to 7 years undergoing elective infraumbilical surgery will be randomly assigned to one of two groups: * Group C (Caudal Group): Receives dexmedetomidine added to the caudal local anesthetic (levobupivacaine) alongside an IV saline placebo infusion. * Group I (Intravenous Group): Receives the caudal local anesthetic alone alongside an IV infusion containing dexmedetomidine. Neither 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.
Trial Details
NCT Number NCT07852039
Lead Sponsor Assiut University
Conditions Postoperative Pain, Caudal Anesthesia, Peripheral Perfusion, Pediatric Surgery
Enrollment 100 participants
Start Date 2026-10
Primary Completion 2027-10 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-01