UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017940 |
|---|---|
| Receipt number | R000020762 |
| Scientific Title | Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/06/17 09:24:09 |
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Basic information
Public title
Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia
Acronym
The influences of Sevoflurane and Desflurane on the postoperative state of pediatric general anesthesia
Scientific Title
Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia
Scientific Title:Acronym
The influences of Sevoflurane and Desflurane on the postoperative state of pediatric general anesthesia
Region
| Japan |
Condition
Condition
pediatic surgery(inguinal hernia, umbilical hernia)
otolaryngological surgery(tonsillar hypertrophy, adenoidal hypertrophy, otitis media)
Classification by specialty
| Pediatrics | Oto-rhino-laryngology | Anesthesiology |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare Desflurane with Sevoflurane for the postoperative quality and possible side effects of pediatric general anesthesia
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of the quality during emergence period(agitation, nausea, vomiting)
Key secondary outcomes
Assessment of the quality at the point of one hour after returning the ward (agitation, nausea, vomiting)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We randomly assign twenty children who undergo pediatric or otolaryngological surgery with 1-6% Sevoflurane at the induction and maintenance of anesthesia.
Interventions/Control_2
We randomly assign twenty children who undergo pediatric or otolaryngological surgery with 1-6% Sevoflurane at the induction and switched to 3-6% Desflurane at the maintenance of anesthesia.
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children 1-6 years old who receives an elective pediatric or otolaryngological surgery
Key exclusion criteria
ASA-PS(ASA physical status)>3 or 4, asthma, body weight>25kg
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Urabe |
Organization
Hiroshima Prefectural Hospital
Division name
Anesthesiology
Zip code
Address
1-5-54 Ujinakanda, Minamiku, Hiroshima-city, Hiroshima-prefecture, Japan 734-8530
TEL
082-3260-5203
tomoakiurabe@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Urabe |
Organization
Hiroshima Prefectural Hospital
Division name
Anesthesiology
Zip code
Address
1-5-54 Ujinakanda, Minamiku, Hiroshima-city, Hiroshima-prefecture, Japan 734-8530
TEL
082-254-1818
Homepage URL
t-yoshimura87638@pref.hiroshima.lg.jp
Sponsor or person
Institute
Hiroshima Prefectural Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
県立広島病院 手術室（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2016 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020762
