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

Strabismus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512355
• Other study ID #: 4-2011-0466
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: July 15, 2015
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Strabismus

Intervention

Drug:
• Dexmedetomidine
After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery
• placebo group
normal saline_02mcg/kg/hr

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective pain score	1. Objective pain score(OPS) Blood pressure 0~2 points crying 0~2points movement 0~2points agitation 0~2points posture 0~2points complain of pain(where appropiraate by age) 0~2points total 0~10 points	immediate postoperative period up to 1hour after surgery	No
Primary	pediatric anesthesia emergence delirium (PAED) scale	2. pediatric anesthesia emergence delirium (PAED) scale The Child makes eye contact with the caregiver 0~4 The child's actions are purposeful. 0~4 The child is aware of his'her surroundings. 0~4 The child is restless. 0~4 The child is insonsolable. 0~4 total 0~20 points	immediate postoperative period up to 1hour after surgery	No
Primary	5-point agitation scale	3. Scoring system for emergence agitation (behavior score); Sleeping; Awake and calm; Irritable and crying; Inconsolable crying; Severe restlessness and disorientation	immediate postoperative period up to 1hour after surgery	No