UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033588 |
|---|---|
| Receipt number | R000038304 |
| Scientific Title | Bispectral index values during general anesthesia in children. |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2018/08/01 15:17:15 |
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Basic information
Public title
Bispectral index values during general anesthesia in children.
Acronym
Bispectral index values and premedication in children.
Scientific Title
Bispectral index values during general anesthesia in children.
Scientific Title:Acronym
Bispectral index values and premedication in children.
Region
| Japan |
Condition
Condition
Pediatric patients scheduled for elective surgery under general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the end-tidal sevoflurane concentration for Bispectral Index 50 of children with clonidine as premedication and that of children without premedication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The end-tidal sevoflurane concentration for maintaining Bispectral Index 50.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 2 | years-old | <= |
Age-upper limit
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with written informed parental concent, ASA I and II, aged 2 to 4 years, and scheduled for elective surgery under general anesthesia.
Key exclusion criteria
severe heart and lung disease, psychic and nervous disease,abnormal ECG, obesity with BMI
>30 kg.m-2, other sedative medication, expected difficult airway management.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko TOKUWAKA |
Organization
University of Tsukuba Hospital
Division name
Department of anesthesiology
Zip code
Address
Amakubo 2 chome 1-1, Tsukuba City, Ibaraki
TEL
029-896-7357
tokuwaka-tuk@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko TOKUWAKA |
Organization
University of Tsukuba Hospital
Division name
Department of anesthesiology
Zip code
Address
Amakubo 2 chome 1-1, Tsukuba City, Ibaraki
TEL
029-896-7357
Homepage URL
tokuwaka-tuk@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, University of Tsukuba
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We record patients` premedication and BIS value after maintaining end-tidal sevoflurane concentration over 10 minutes. Then we evaluate end-tidal concentration of sevoflurane for BIS 50 using logistic analysis until we gain significant confidence interval.
Management information
Registered date
| 2018 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038304
