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Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
Sponsor: Assiut University
Summary
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.
Official title: Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery: A Randomized Double-Blind Controlled Study
Key Details
Gender
All
Age Range
1 Year - 7 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10
Completion Date
2027-11
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
Caudal Dexmedetomidine
Dexmedetomidine (1 µg/kg) combined with 0.25% levobupivacaine (total volume 1 mL/kg) 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.
Intravenous Dexmedetomidine
Dexmedetomidine (1 µg/kg) 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/kg) administered over 60 seconds under general anesthesia.