Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery

September 18, 2012 updated by: Yonsei University
Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

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 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • ASA class I
  • obtaining written informed consent from the parents
  • aged 1-5 years, and weighing <20 kg who were undergoing ambulatory hernioplasty or orchiopexy

Exclusion Criteria:

  • mental retardation
  • developmental delays
  • neurological or psychiatric illnesses
  • coagulation disorder
  • spinal anomalies
  • bilateral procedures

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine
Drug: Dexmedetomidine
dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.
Placebo Comparator: placebo group
normal saline
Drug: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the reduction rate of ET-sevo in achieving BIS scores from 45-50
Time Frame: 2 hour(during whole operation period)
2 hour(during whole operation period)

Collaborators and Investigators

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

Sponsor

Yonsei University

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

August 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0430

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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