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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01578161

Enrollment

116

Registered

2012-04-16

Start date

2012-01-31

Completion date

2013-04-30

Last updated

2012-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychomotor Agitation

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.

Interventions

DRUGDexmedetomidine

DRUG0.9% Normal Saline

Placebo,Normal saline 10ml ivs. for 10min.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Agitation score	30 mins after operation

Secondary

Measure	Time frame
Oculomotor reflex	Intraoperative

Countries

South Korea

Contacts

Primary ContactINAE SONG

nodame1@naver.com82-10-2609-2401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026