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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014582
Receipt No. R000016887
Scientific Title Bispectral index values during general anesthesia in children.
Date of disclosure of the study information 2014/07/18
Last modified on 2014/07/17

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Basic information
Public title Bispectral index values during general anesthesia in children.
Acronym The relationship between bispectral index values and age in children.
Scientific Title Bispectral index values during general anesthesia in children.
Scientific Title:Acronym The relationship between bispectral index values and age in children.
Region
Japan

Condition
Condition Pediatric patients scheduled for minor surgery such as inguinal herniorrhaphy or cryptorchidism repair.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the minimum alveolar sevoflurane concentration for maintaining the BIS below 50 in narrow age ranges in children.
Basic objectives2 Others
Basic objectives -Others A BIS target below 50 is considered appropriate for maintaining unconsciousness during general anesthesia.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The end-tidal sevoflurane concentration for maintaining the BIS below 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
1 years-old <=
Age-upper limit
9 years-old >=
Gender Male and Female
Key inclusion criteria Pediatric patients with written informed parental consent, ASA I and II, aged 1 to 9 years, and scheduled for elective minor surgeries such as inguinal herniorrhaphy or cryptorchidism repair under general anesthesia.
Key exclusion criteria A history of cardiovascular, respiratory or psychological diseases, abnormal electrocardiogram, obesity with BMI > 30 kg.m-2, expected difficult airway management, and parental request for premedication.
Target sample size 55

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Satsumae
Organization University of Tsukuba
Division name Department of Anesthesiology
Zip code
Address Tennodai 1-1-1, Tsukuba City, Ibaraki
TEL 029-853-3092
Email tsuu@md.tsukuba.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tsuyoshi Satsumae
Organization University of Tsukuba
Division name Department of Anesthesiology
Zip code
Address Tennodai 1-1-1, Tsukuba City, Ibaraki
TEL 029-853-3092
Homepage URL
Email tsuu@md.tsukuba.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)

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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 18 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
In the 1 year-old group, the bispectral index values remained high, with the end-tidal sevoflurane concentration reaching 4.0% or higher. The minimum alveolar concentration of sevoflurane for maintaining the bispectral index below 50 was significantly higher in young children (P = 0.0047): 2.33% in the 2-to 4-year-old group and 2.10% in the 5- to 9-year-old group.
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
2012 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 05 Month 24 Day

Other
Other related information At first, end-tidal sevoflurane concentration was adjusted to 2.8% followed by a 1-min assessment of BIS taken at 10-sec intervals. If a patient had an average BIS of < 50, the sevoflurane concentration was reduced by 0.2% in the next patient, whereas if a patient had a BIS <= 50, the sevoflurane concentration was increased by 0.2% in the next patient. The minimum alveolar sevoflurane concentration for maintaining the bispectral index below 50 was determined using the Dixon's up-and-down method and probit analysis.

Management information
Registered date
2014 Year 07 Month 17 Day
Last modified on
2014 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016887

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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