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

NCT07852039 | Not Yet Recruiting Phase 4

• 1 other identifier: IV vs Caudal Dexmedetomidine
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Caudal Anesthesia; Peripheral Perfusion; Pediatric Surgery; Postoperative Pain

Keywords

Dexmedetomidine; Perfusion Index; Caudal Block; Levobupivacaine; Hemodynamics; Infraumbilical Surgery; Pediatric Anesthesia; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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/DC 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

Study Arms (2)

Group C: Caudal Dexmedetomidine

ACTIVE COMPARATOR

Participants receive a caudal block containing 0.25% levobupivacaine (1 mL/kg) combined with dexmedetomidine (1 µg/kg) injected over 60 seconds, accompanied by a simultaneous intravenous placebo infusion of 20 mL normal saline administered over 10 minutes.

Drug: Caudal Dexmedetomidine

Group I: Intravenous Dexmedetomidine

EXPERIMENTAL

Participants receive a caudal block containing 0.25% levobupivacaine (1 mL/kg) alone injected over 60 seconds, accompanied by a simultaneous intravenous infusion of dexmedetomidine (1 µg/kg) diluted in 20 mL normal saline administered over 10 minutes.

Drug: Intravenous Dexmedetomidine

Interventions

Caudal Dexmedetomidine DRUG

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.

Group C: Caudal Dexmedetomidine

Intravenous Dexmedetomidine DRUG

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.

Group I: Intravenous Dexmedetomidine

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 1 to 7 years.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Scheduled for elective infraumbilical surgery.
• Anticipated duration of surgery less than 120 minutes.
• Written informed consent obtained from parents or legal guardians.

You may not qualify if:

• Coagulopathy or bleeding disorders.
• Pre-existing local infection at the caudal injection site.
• Known congenital heart disease.
• Neurological or neuromuscular disorders.
• Known allergy or hypersensitivity to dexmedetomidine, local anesthetics, or any study medication.
• Significant developmental delay affecting pain assessment.
• Failed caudal block.
• Parental or guardian refusal to participate.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09