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

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Yonsei University

Status

Completed

Conditions

Ambulation Difficulty

Treatments

Drug: Dexmedetomidine
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01691001
4-2011-0430

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

dexmedetomidine
Experimental group
Treatment:
Drug: Dexmedetomidine
placebo group
Placebo Comparator group
Description:
normal saline
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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