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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01691001

Enrollment

Registered

2012-09-24

Start date

2011-08-31

Completion date

2012-03-31

Last updated

2012-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulation Difficulty

Brief summary

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.

Interventions

DRUGDexmedetomidine

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

DRUGnormal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

1 Years to 5 Years

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

Design outcomes

Primary

Measure	Time frame
the reduction rate of ET-sevo in achieving BIS scores from 45-50	2 hour(during whole operation period)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026