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Clinical Trials in Egypt / NCT07035184
Starting soon Not applicable

A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia in Children Undergoing Elective Infra-Umbilical Surgeries

NCT07035184 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Not applicable
Started
2025-08-01
Last updated
2025-06-25

Condition(s) studied

PediatricsSpinal AneshtesiaInfraumbilical Surgeries

Investigational drug(s) / intervention(s)

Spinal Anesthesia with BupivacaineSpinal Anesthesia with Bupivacaine

Spinal Anesthesia with Bupivacaine: Group A (n=30) will receive spinal anesthesia according to the weight-based dosing calculation of bupivacaine.

Spinal Anesthesia with Bupivacaine: Group B (n=30) will receive spinal anesthesia according to the age-based dosing calculation of bupivacaine.

Study summary

This prospective randomized double-blinded controlled trial will include 60 pediatric patients aged 1 - 6 years old, both sexes, with American society of anesthesiologists (I and II) and undergoing elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes. Patients will be randomly divided into two equal groups: Weight-based dosing (Group A) and age-based dosing group (Group B). Both groups will receive hyperbaric bupivacaine 0.5%. The aim of the study is to evaluate the effectiveness of using age based dosing of Bupivacaine compared with standard method of weight based dosing in pediatric spinal anesthesia.

Eligibility

Sex
ALL
Min age
1 Year
Max age
6 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged 1-6 years * Both genders. * American Society of Anesthesiologists (ASA) physical status I or II. * Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes. Exclusion Criteria: * Guardian refusal. * Children with significant congenital heart disease (e.g., septal defects requiring surgical intervention) * Children with neuromuscular disorders or high intracranial pressure. * Children with spinal deformities or morbid obesity (body mass index (BMI) above the 99th percentile). * Children with a history or family history of coagulation disorders. * Children with local infection at the site of skin puncture for spinal anesthesia. * Children with known allergy to Bupivacaine. * Surgeries requiring Trendelenburg or prone position. * Unexpected prolongation of surgery \> 90 minutes

Primary outcome measure(s)

  • The peak sensory level — Assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch up to 30 minutes after subarachnoid block
    The peak sensory level will be assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch.

Trial sites (1)

FacilityCityRegionStatus
Abu Elreesh Pediatric Hospital Cairo Assida Zainab

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035184 on ClinicalTrials.gov ↗ ← All trials in Egypt