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

Ambulation Difficulty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691001
• Other study ID #: 4-2011-0430
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: September 18, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ambulation Difficulty

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the reduction rate of ET-sevo in achieving BIS scores from 45-50		2 hour(during whole operation period)	No