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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033588
Receipt No. R000038304
Official scientific title of the study Bispectral index values during general anesthesia in children.
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/01

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Basic information
Official scientific title of the study Bispectral index values during general anesthesia in children.
Title of the study (Brief title) 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 Junko TOKUWAKA
Organization University of Tsukuba Hospital
Division name Department of anesthesiology
Address Amakubo 2 chome 1-1, Tsukuba City, Ibaraki
TEL 029-896-7357
Email tokuwaka-tuk@umin.ac.jp

Public contact
Name of contact person Junko TOKUWAKA
Organization University of Tsukuba Hospital
Division name Department of anesthesiology
Address Amakubo 2 chome 1-1, Tsukuba City, Ibaraki
TEL 029-896-7357
Homepage URL
Email tokuwaka-tuk@umin.ac.jp

Sponsor
Institute Department of Anesthesiology, University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038304

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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