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

Not Applicable

Completed

• Conditions: Ambulation Difficulty
• Interventions: Drug: normal saline; Drug: Dexmedetomidine

• Registration Number: NCT01691001
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Study First Posted: 2012-09-24
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	normal saline	normal saline
dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of