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Completed

NCT Number: NCT01691001

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

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.

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Key information

Age range

1 year–5 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.

normal saline

Drug

Primary outcomes

  1. the reduction rate of ET-sevo in achieving BIS scores from 45-50

    Time frame: 2 hour(during whole operation period)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 24, 2012
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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