The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

April 13, 2012 updated by: Ah-Young Oh, Seoul National University Hospital
After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Korea, Republic of
    • Kyonggi do
      • SungNam-si, Kyonggi do, Korea, Republic of, 463-707
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • AhYoung Oh

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

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physical status classification of American Society of Anesthesiologist 1-2,
  • Healthy, normal
  • 2-6 years old
  • Elective operation

Exclusion Criteria:

  • Lack of consent
  • Known adverse effects to dexmedetomidine, mental retardation
  • Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
  • No cardiac disease

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
EXPERIMENTAL: Dexmedetomidine0.25
dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.
Drug: Dexmedetomidine
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
Other Names:
  • Precedex
EXPERIMENTAL: Dexmedetomidine0.5
dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.
Drug: Dexmedetomidine
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
Other Names:
  • Precedex
EXPERIMENTAL: Dexmedetomidine1.0
dexmedetomidine 1 microg.kg(-1) ivs. for 10min.
Drug: Dexmedetomidine
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
Other Names:
  • Precedex
PLACEBO_COMPARATOR: NormalSaline
Normal saline 10ml ivs. for 10min.
Drug: 0.9% Normal Saline
Placebo,Normal saline 10ml ivs. for 10min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Agitation score
Time Frame: 30 mins after operation
30 mins after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Oculomotor reflex
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: AhYoung Oh, Seoul National University Bundang Hospital

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

January 1, 2012

Primary Completion (ANTICIPATED)

January 1, 2013

Study Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (ESTIMATE)

April 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2012

Last Update Submitted That Met QC Criteria

April 13, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_01

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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