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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010763
Receipt No. 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

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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
Email 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
Email iloklee@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012583

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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