Sevoflurane AnaesthesiaNCT01880138
Effect of Animated Cartoon for Prevention of Emergence Agitation in Children Aged 1.5 - 5 yr After General Anesthesia
A study testing watching animated cartoon before general anesthesia and not watching animated cartoon beofre general anaesthesia in people with Sevoflurane Anaesthesia, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 months to 5 years
- Conditions the study is for
- Sevoflurane Anaesthesia
- What is being tested?
- watching animated cartoon before general anesthesia and not watching animated cartoon beofre general anaesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
Seoul, Seoul, 120-752
Jeong-Rim LEE, MD, PhD, 02-2227-3840, MANYA@yuhs.ac
About this study
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
- Conditions
- Sevoflurane Anaesthesia
- Being tested
- watching animated cartoon before general anesthesia, not watching animated cartoon beofre general anaesthesia
- Keywords
- Animated cartoon, Emergence agitation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
watching animated cartoon before general anesthesiaOther
not watching animated cartoon beofre general anaesthesiaOther
| Study group | Role | What they receive |
|---|---|---|
| watching animated cartoon | Experimental | Not described Receives: Other: watching animated cartoon before general anesthesia |
| not watching animated cartoon | Placebo comparator | Not described Receives: Other: not watching animated cartoon beofre general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium (PAED) Scale
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'.
Measured: (PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sevoflurane AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880138
- Sponsor's protocol ID
- 4-2013-0192
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Animated Cartoon for Prevention of Emergence Agitation in Children Aged 1.5 - 5 yr After General Anesthesia
- ClinicalTrials.gov ID
- NCT01880138
- Acronym / sponsor ID
- 4-2013-0192
- Conditions
- Sevoflurane Anaesthesia
- Keywords
- Animated cartoon, Emergence agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| watching animated cartoon | Experimental | Other: watching animated cartoon before general anesthesia |
| not watching animated cartoon | Placebo comparator | Other: not watching animated cartoon beofre general anaesthesia |
Who may qualify
- Ages
- 17 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| watching animated cartoon before general anesthesia | Other | watching animated cartoon |
| not watching animated cartoon beofre general anaesthesia | Other | not watching animated cartoon |
Primary outcome
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'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing watching animated cartoon before general anesthesia and not watching animated cartoon beofre general anaesthesia in people with Sevoflurane Anaesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Rim LEE, MD, PhD (02-2227-3840, MANYA@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anesthesia Emergence Delirium (PAED) Scale (time frame: (PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.