The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

Phase 4

• Conditions: Psychomotor Agitation
• Interventions: Drug: Dexmedetomidine; Drug: 0.9% Normal Saline

• Registration Number: NCT01578161
• Lead Sponsor: Seoul National University Hospital

Brief Summary

After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

Detailed Description

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-13
• Last Update Submitted: 2012-04-13
• Study First Posted: 2012-04-16
• Last Update Posted: 2012-04-16
• Primary Completion: 2013-01
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Physical status classification of American Society of Anesthesiologist 1-2,
• Healthy, normal
• 2-6 years old
• Elective operation

Exclusion Criteria

• Lack of consent
• Known adverse effects to dexmedetomidine, mental retardation
• Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
• No cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine0.25	Dexmedetomidine	dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.
Dexmedetomidine0.5	Dexmedetomidine	dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.
Dexmedetomidine1.0	Dexmedetomidine	dexmedetomidine 1 microg.kg(-1) ivs. for 10min.
NormalSaline	0.9% Normal Saline	Normal saline 10ml ivs. for 10min.

Primary Outcome Measures

Name	Time	Method
Agitation score	30 mins after operation

Secondary Outcome Measures

Name	Time	Method
Oculomotor reflex	Intraoperative

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL; 🇰🇷 SungNam-si, Kyonggi do, Korea, Republic of