Diverticulectomy, Fistula Repair, Hydrocelectomy, Inguinal Hernioplasty, Orchiopexy, Penoplasty
Conditions
Brief summary
The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.
Interventions
DRUG1.0 ml/kg of 0.15% ropivacaine
Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.
DRUG1.5 ml/kg of 0.15% ropivacaine
Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients * weighing less than 16 kg * who receive caudal block before urologic surgery
Exclusion criteria
* Subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure * ophthalmic disease * expected operation time is less than 30 minutes * both parents are unable to communicate or speak Korean.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the optic nerve sheath diameter between groups | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| The variation in the optic nerve sheath diameter before and after caudal block | 30 minutes |
| the difference in the variation of the optic nerve sheath diameter between groups | 30 minutes |
Countries
South Korea
Outcome results
None listed