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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01691001
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ambulation Difficulty Drug: Dexmedetomidine Drug: normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. the reduction rate of ET-sevo in achieving BIS scores from 45-50 [ Time Frame: 2 hour(during whole operation period) ]

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01691001

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT01691001     History of Changes
Other Study ID Numbers: 4-2011-0430
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action