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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01512355
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 14.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Strabismus	Drug: Dexmedetomidine; Drug: placebo group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexmedetomidine	Drug: Dexmedetomidine; After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery
Placebo Comparator: placebo	Drug: placebo group; normal saline_02mcg/kg/hr

Outcome Measures

Primary Outcome Measures

1. objective pain score [immediate postoperative period up to 1hour after surgery]

   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

2. pediatric anesthesia emergence delirium (PAED) scale [immediate postoperative period up to 1hour after surgery]

   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

3. 5-point agitation scale [immediate postoperative period up to 1hour after surgery]

   3. Scoring system for emergence agitation (behavior score) Sleeping Awake and calm Irritable and crying Inconsolable crying Severe restlessness and disorientation

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01512355
• Other Study ID Numbers: 4-2011-0466
• First Posted: Jan 19, 2012
• Last Update Posted: Jul 16, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Strabismus; Dexmedetomidine

Study Results

No Results Posted as of Jul 16, 2015