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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01578161
Other study ID # SNUBH_01
Secondary ID
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


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
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