ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01374737
First received: June 9, 2011
Last updated: June 15, 2011
Last verified: June 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tonsillectomy or adenoidectomy

Exclusion Criteria:

  • recent URI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hee-Soo Kim, SNUH
ClinicalTrials.gov Identifier: NCT01374737     History of Changes
Other Study ID Numbers: KHS_1
Study First Received: June 9, 2011
Last Updated: June 15, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 20, 2014