UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014582 |
|---|---|
| Receipt number | 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 17:50:26 |
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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
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
tsuu@md.tsukuba.ac.jp
Public contact
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
tsuu@md.tsukuba.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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016887
