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

June 13, 2014 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei Univ. College of Medicine Dep. Of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • children undergoing ambulatory orchiopexy,
  • ASA status I

Exclusion Criteria:

  • mental retardation,
  • developmental delay,
  • neurological or psychiatric illness,
  • coagulation disorder,
  • spinal anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Caudal ropivacaine + normal saline
1.5ml kg-1 ropivacaine 0.15% with normal saline (Control group, n=40).
Drug: Caudal ropivacaine + normal saline
Experimental: Caudal ropivacaine + dexmedetomidine
1.5ml kg-1 ropivacaine 0.15% with dexmedetomidine 1 μg kg-1 (DEX group, n=40)
Drug: Caudal ropivacaine + dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital sign
Time Frame: up to 180 min after surgery
systolic arterial pressure
up to 180 min after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inhalation anesthetics requirements
Time Frame: up to 180 min after surgery
end-tidal sevoflurane concentration required to maintain hemodynamic changes < 20% of the preoperative baseline
up to 180 min after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of agitation
Time Frame: up to 180 min after surgery
number of patients
up to 180 min after surgery
sedation score
Time Frame: up to 180 min after surgery
three-point scale (0=eyes open spontaneously, 1=verbal stimulation, 2=physical stimulation
up to 180 min after surgery
pain scores
Time Frame: up to 180 min after surgery
Face Legs Activity Cry, Consolability scale (FLACC) Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
up to 180 min after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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