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

Psychomotor Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01578161
• Other study ID #: SNUBH_01
• Status: Recruiting
• Phase: Phase 4
• First received: April 13, 2012
• Last updated: April 13, 2012
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2012
• Source: Seoul National University Hospital
• Contact: INAE SONG
• Phone: 82-10-2609-2401
• Email: nodame1[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Psychomotor Agitation

Intervention

Drug:
• Dexmedetomidine
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.
• 0.9% Normal Saline
Placebo,Normal saline 10ml ivs. for 10min.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL	SungNam-si	Kyonggi do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agitation score		30 mins after operation	No
Secondary	Oculomotor reflex		Intraoperative	Yes