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

NCT ID: NCT02768493

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Orchiopexy Inguinal Hernioplasty Hydrocelectomy Diverticulectomy Fistula Repair Penoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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low dose group

Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.

Group Type EXPERIMENTAL

1.0 ml/kg of 0.15% ropivacaine

Intervention Type DRUG

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.

high dose group

Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.

Group Type ACTIVE_COMPARATOR

1.5 ml/kg of 0.15% ropivacaine

Intervention Type DRUG

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.

Interventions

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1.0 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.

Intervention Type DRUG

1.5 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Girisgin AS, Kalkan E, Kocak S, Cander B, Gul M, Semiz M. The role of optic nerve ultrasonography in the diagnosis of elevated intracranial pressure. Emerg Med J. 2007 Apr;24(4):251-4. doi: 10.1136/emj.2006.040931.

Reference Type BACKGROUND
PMID: 17384377 (View on PubMed)

Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.

Reference Type BACKGROUND
PMID: 21505900 (View on PubMed)

Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.

Reference Type BACKGROUND
PMID: 22258019 (View on PubMed)

Lundblad M, Forestier J, Marhofer D, Eksborg S, Winberg P, Lonnqvist PA. Reduction of cerebral mean blood flow velocity and oxygenation after high-volume (1.5 ml kg(-)(1)) caudal block in infants. Br J Anaesth. 2014 Oct;113(4):688-94. doi: 10.1093/bja/aeu161. Epub 2014 Jun 27.

Reference Type BACKGROUND
PMID: 24972788 (View on PubMed)

Lee B, Koo BN, Choi YS, Kil HK, Kim MS, Lee JH. Effect of caudal block using different volumes of local anaesthetic on optic nerve sheath diameter in children: a prospective, randomized trial. Br J Anaesth. 2017 May 1;118(5):781-787. doi: 10.1093/bja/aex078.

Reference Type DERIVED
PMID: 28486629 (View on PubMed)

Other Identifiers

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4-2016-0192

Identifier Type: -

Identifier Source: org_study_id

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