Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics

NCT ID: NCT02163980

Last Updated: 2014-06-16

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

2011-05-31

Study Completion Date

2011-07-31

Brief Summary

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The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.

Detailed Description

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Conditions

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Ambulatory Orchipexy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Caudal ropivacaine + normal saline

1.5ml kg-1 ropivacaine 0.15% with normal saline (Control group, n=40).

Group Type PLACEBO_COMPARATOR

Caudal ropivacaine + normal saline

Intervention Type DRUG

Caudal ropivacaine + dexmedetomidine

1.5ml kg-1 ropivacaine 0.15% with dexmedetomidine 1 μg kg-1 (DEX group, n=40)

Group Type EXPERIMENTAL

Caudal ropivacaine + dexmedetomidine

Intervention Type DRUG

Interventions

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Caudal ropivacaine + normal saline

Intervention Type DRUG

Caudal ropivacaine + dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* children undergoing ambulatory orchiopexy,
* ASA status I

Exclusion Criteria

* mental retardation,
* developmental delay,
* neurological or psychiatric illness,
* coagulation disorder,
* spinal anomalies
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

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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Yonsei Univ. College of Medicine Dep. Of Anesthesiology

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Cho JE, Kim JY, Park SJ, Kil HK. The Effect of 1 microg/kg Dexmedetomidine Combined with High-Volume/Low-Concentration Caudal Ropivacaine in Children Undergoing Ambulatory Orchiopexy. Biol Pharm Bull. 2015;38(7):1020-5. doi: 10.1248/bpb.b15-00086.

Reference Type DERIVED
PMID: 26133711 (View on PubMed)

Other Identifiers

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4-2011-0111

Identifier Type: -

Identifier Source: org_study_id

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