ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

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: NCT01374737
Recruitment Status : Unknown
Verified June 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 16, 2011
Last Update Posted : June 16, 2011
Information provided by:
Seoul National University Hospital

Brief Summary:
There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

Condition or disease Intervention/treatment Phase
Agitation Drug: Dexmedetomidine Phase 4

Detailed Description:
To investigate ED50, Dixon's up and down method will be used.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ED50 of Dexmedetomidine for Reduction of Emergence Agitation Incidence Undergoing Tonsillectomy or Adenoidectomy in Desflurane Anesthesia Following Sevoflurane Induction in Children
Study Start Date : June 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
dexmedetomidine, children Drug: Dexmedetomidine
dexmedetomidine, 0.1ug/kg up or down
Other Name: precedex

Primary Outcome Measures :
  1. agitation [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. pain [ Time Frame: 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • tonsillectomy or adenoidectomy

Exclusion Criteria:

  • recent URI

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): NCT01374737

Contact: Hee-Soo Kim, M.D., PhD 82220723659

Korea, Republic of
SNUH Recruiting
Seoul, Korea, Republic of, 110744
Contact: Hee-Soo Kim, M.D., PhD    82220723659   
Sub-Investigator: Hyo-Jin Byon, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Study Director: Hee-Soo Kim, M.D, PhD Seoul National University Hospital

Responsible Party: Hee-Soo Kim, SNUH Identifier: NCT01374737     History of Changes
Other Study ID Numbers: KHS_1
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
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