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ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374737
First Posted: June 16, 2011
Last Update Posted: June 16, 2011
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.
Information provided by:
Seoul National University Hospital
  Purpose
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 Intervention Phase
Agitation Drug: Dexmedetomidine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • agitation [ Time Frame: 30 minutes ]

Secondary Outcome Measures:
  • pain [ Time Frame: 30 minutes ]

Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dexmedetomidine, children Drug: Dexmedetomidine
dexmedetomidine, 0.1ug/kg up or down
Other Name: precedex

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

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
Criteria

Inclusion Criteria:

  • tonsillectomy or adenoidectomy

Exclusion Criteria:

  • recent URI
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01374737


Contacts
Contact: Hee-Soo Kim, M.D., PhD 82220723659 dami0605@snu.ac.kr

Locations
Korea, Republic of
SNUH Recruiting
Seoul, Korea, Republic of, 110744
Contact: Hee-Soo Kim, M.D., PhD    82220723659    dami0605@snu.ac.kr   
Sub-Investigator: Hyo-Jin Byon, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Hee-Soo Kim, M.D, PhD Seoul National University Hospital
  More Information

Responsible Party: Hee-Soo Kim, SNUH
ClinicalTrials.gov Identifier: NCT01374737     History of Changes
Other Study ID Numbers: KHS_1
First Submitted: June 9, 2011
First Posted: June 16, 2011
Last Update Posted: June 16, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
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