Clinical Trials Directory

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UnknownNCT03911804

The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
4 Years – 13 Years
Healthy volunteers
Not accepted

Summary

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 continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural analgesia before osteotomy will be divided into bolus group (n=30) and infusion group (n=30). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia. The primary endpoint is the difference in the optic nerve sheath diameter after epidural analgesia measured by optic nerve ultrasonography between groups.

Conditions

Interventions

TypeNameDescription
PROCEDUREbolus group and infusion group for epidural blockRandomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.

Timeline

Start date
2019-04-01
Primary completion
2021-03-01
Completion
2021-03-01
First posted
2019-04-11
Last updated
2019-04-11

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03911804. Inclusion in this directory is not an endorsement.