UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020092 |
|---|---|
| Receipt number | R000023181 |
| Scientific Title | Bispectral index values during general anesthesia using desflurane. |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2017/07/28 12:15:56 |
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Basic information
Public title
Bispectral index values during general anesthesia using desflurane.
Acronym
The relationship between bispectral index values and age.
Scientific Title
Bispectral index values during general anesthesia using desflurane.
Scientific Title:Acronym
The relationship between bispectral index values and age.
Region
| Japan |
Condition
Condition
Patients scheduled for surgical treatment under general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the minimum alveolar desflurane concentration for maintaining the BIS below 50 in adults and 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 desflurane 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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with written informed consent, American Society of Anesthesiologists (ASA) physical status I and II, aged 5 to 90 years, and scheduled for elective surgery under general anesthesia.
Key exclusion criteria
A history of cardiovascular, respiratory or psychological diseases, abnormal electrocardiogram (ECG), obesity with BMI > 30 kg.m-2, expected difficult airway management, and parental request for premedication.
Target sample size
120
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
| 2015 | Year | 12 | Month | 07 | 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
The minimum alveolar concentration of desflurane was calculated to be 4.17%, 3.53%, 3.33% in the 10-19 year-old, 20-39 year-old, and 40-69 year-old group, respectively. The minimum alveolar concentration of desflurane decreases with advance in age (P = 0.007).
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
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design:
cross-sectional study
Way for subscription of patients:
patients who were scheduled for elective surgery under general anesthesia after institutional review board approval and written informed consent from August 2014
Measurement parameters:
heart rate, blood pressure, SPO2, BIS values, end-tidal CO2 concentration
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023181
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
