The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
This study is currently recruiting participants.
Verified January 2012 by Yonsei University
Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01512355
First received: January 9, 2012
Last updated: January 13, 2012
Last verified: January 2012
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Purpose
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 | Intervention |
|---|---|
|
Strabismus |
Drug: Dexmedetomidine Drug: placebo group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- objective pain score [ Time Frame: immediate postoperative period up to 1hour after surgery ] [ Designated as safety issue: No ]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
- pediatric anesthesia emergence delirium (PAED) scale [ Time Frame: immediate postoperative period up to 1hour after surgery ] [ Designated as safety issue: No ]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
- 5-point agitation scale [ Time Frame: immediate postoperative period up to 1hour after surgery ] [ Designated as safety issue: No ]
3. Scoring system for emergence agitation (behavior score)
- Sleeping
- Awake and calm
- Irritable and crying
- Inconsolable crying
- Severe restlessness and disorientation
| Estimated Enrollment: | 88 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512355
Contacts
| Contact: Bon-Nyeo Koo, MD | 82-2-2228-2420 | koobn@yuhs.ac |
| Contact: Jeong-Min Kim, MD | 82-2-2228-2420 | ANESJEONGMIN@yuhs.ac |
Locations
| Korea, Republic of | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Bon-nyeo Koo, MD 82-2-2228-2420 koobn@yuhs.ac | |
Sponsors and Collaborators
Yonsei University
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01512355 History of Changes |
| Other Study ID Numbers: | 4-2011-0466 |
| Study First Received: | January 9, 2012 |
| Last Updated: | January 13, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Strabismus Ocular Motility Disorders Cranial Nerve Diseases Nervous System Diseases Eye Diseases Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013