Emergency Agitation in T&A

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01152476
First received: June 25, 2010
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.


Condition Intervention
Healthy
Drug: remifentanil
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • emergency agitation [ Time Frame: during 1 hour after recovering of anesthesia ] [ Designated as safety issue: No ]
    at post-anesthetic care unit


Estimated Enrollment: 42
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group SR Drug: remifentanil
General anesthesia is maintained witn sevoflurane and remifentanil.
Active Comparator: group S Drug: normal saline
General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologist physical status I or II
  • 2-6 year-old children
  • patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria:

  • upper respiratory disease
  • mental retardation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01152476

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01152476     History of Changes
Other Study ID Numbers: T&A_EA
Study First Received: June 25, 2010
Last Updated: January 5, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
healthy pediatric patients undergoing tonsillectomy and adenoidectomy

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 10, 2014