Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block

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Yonsei University

Status

Completed

Conditions

Penoplasty
Inguinal Hernioplasty
Fistula Repair
Orchiopexy
Diverticulectomy
Hydrocelectomy

Treatments

Drug: 1.5 ml/kg of 0.15% ropivacaine
Drug: 1.0 ml/kg of 0.15% ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02768493
4-2016-0192

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

6 months to 4 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

low dose group
Experimental group
Description:
Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.
Treatment:
Drug: 1.0 ml/kg of 0.15% ropivacaine
high dose group
Active Comparator group
Description:
Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.
Treatment:
Drug: 1.5 ml/kg of 0.15% ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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