The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery

Yonsei University

Status: Completed

Conditions: Strabismus

Treatments: Drug: placebo group; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01512355

4-2011-0466

Details and patient eligibility

About

Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.

Enrollment: 88 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the patient undergoing the strabismus surgery in severance hospital

Exclusion criteria

• delayed development
• mental retardation
• cerebral palsy
• preoperative EKG abnormality e.g. cardiovascular conduction disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

dexmedetomidine

Experimental group

Treatment:

Drug: Dexmedetomidine

placebo

Placebo Comparator group

Treatment:

Drug: placebo group