UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010763 |
|---|---|
| Receipt number | R000012583 |
| Scientific Title | Emergence agitation in pediatric patients after sevoflurane anesthesia without nitrous oxide or combination with nitrous oxide |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2014/04/28 10:04:54 |
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Basic information
Public title
Emergence agitation in pediatric patients after sevoflurane anesthesia without nitrous oxide or combination with nitrous oxide
Acronym
emergence agitation after sevoflurane without nitrous oxude
Scientific Title
Emergence agitation in pediatric patients after sevoflurane anesthesia without nitrous oxide or combination with nitrous oxide
Scientific Title:Acronym
emergence agitation after sevoflurane without nitrous oxude
Region
| Asia(except Japan) |
Condition
Condition
tonsillectomy and adenoidectomy surgery
Classification by specialty
| Pediatrics | Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare the emergence agitation, recovery time of children assigned to receive sevoflurane (group S) or sevoflurane with N2O (group N)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anesthetic maintenance using sevoflurane without nitrous oxide is associated with a higher end tidal concentration of sevoflurane at emergence than sevoflurane with nitrous oxide; however, this difference may be dose-related. The anesthetic properties of these two maintenance methods do not seem to have a role in the incidence of emergence delirium or recovery profile.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
anesthesia was maintained with sevoflurane alone in the group S
Interventions/Control_2
anesthesia was maintained with 50% N2O and sevoflurane in the group N
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients scheduled for elective surgery of tonsillectomy and adenoidectomy
Key exclusion criteria
Patients with a history of cardiovascular, respiratory (asthma), neurologic (seizure), kidney, liver disease, mood disorder, prematurity, or developmental delay, the presence of upper respiratory infection, hypersensitivity to drugs, and those receiving analgesics, sedatives or psychiatric medication were excluded.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
Gurodong-ro 148, Guro-gu, Seoul, Republic of Korea
TEL
82-2-2626-3234
iloklee@korea.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
gurodong-ro 148, guro-gu, Seoul, Republic of Korea
TEL
82-2-2626-3234
Homepage URL
iloklee@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
Funding Source
Organization
Korea University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 20 | Day |
Last modified on
| 2014 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012583
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
