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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Psychomotor Agitation

Treatments: Drug: Dexmedetomidine; Drug: 0.9% Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01578161

SNUBH_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 4 patient groups, including a placebo group

Dexmedetomidine0.25

Experimental group

Description:

dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine0.5

Experimental group

Description:

dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine1.0

Experimental group

Description:

dexmedetomidine 1 microg.kg(-1) ivs. for 10min.

Treatment:

Drug: Dexmedetomidine

NormalSaline

Placebo Comparator group

Description:

Normal saline 10ml ivs. for 10min.

Treatment:

Drug: 0.9% Normal Saline