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Effect of Animated Cartoon for Prevention of Emergence Agitation in Children Aged 1.5 - 5 yr After General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880138
Recruitment Status : Unknown
Verified June 2013 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : June 18, 2013
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the risk of EA for each increment of 10 points in the child's state anxiety score. So, Alleviates preoperative anxiety in Children maybe decrease the incidence and severity of EA. Preschool children enjoy watching animated cartoons, and they can be immersed to animated cartoon so they become oblivious of their surroundings. Therefore, viewing an animated cartoon maybe reduce preoperative anxiety in children. This study was performed to determine effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after general anesthesia

Condition or disease Intervention/treatment Phase
Sevoflurane Anaesthesia Other: watching animated cartoon before general anesthesia Other: not watching animated cartoon beofre general anaesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : June 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: watching animated cartoon Other: watching animated cartoon before general anesthesia
Placebo Comparator: not watching animated cartoon Other: not watching animated cartoon beofre general anaesthesia



Primary Outcome Measures :
  1. Pediatric Anesthesia Emergence Delirium (PAED) Scale [ Time Frame: (PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours ]
    Subjects' behavior was rated in the post-anesthesia care unit (PACU) from the moment subjects opened their eyes, and every 5 minutes until discharge from the PACU. The Pediatric Anesthesia Emergence Delirium (PAED) Scale (Sikich & Lerman, 2004) was used. The scale assesses 5 behaviors (making eye contact, purposefulness of actions, awareness of surroundings, restlessness, and consolability) on a 5-point scale that ranges from 'not at all' to 'extremely'.



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Ages Eligible for Study:   17 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia

Exclusion Criteria:

1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880138


Contacts
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Contact: Jeong-Rim LEE, MD, PhD 02-2227-3840 MANYA@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong-Rim LEE, MD, PhD    02-2227-3840    MANYA@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01880138    
Other Study ID Numbers: 4-2013-0192
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Yonsei University:
Animated cartoon, Emergence agitation
Additional relevant MeSH terms:
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Emergence Delirium
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs