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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032960
Receipt No. R000037576
Official scientific title of the study Comparison of the minimum alveolar concentrations of desflurane and sevoflurane required for maintaining bispectral index below 50 between elderly and super-elderly patients
Date of disclosure of the study information 2018/06/12
Last modified on 2018/06/12

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Basic information
Official scientific title of the study Comparison of the minimum alveolar concentrations of desflurane and sevoflurane required for maintaining bispectral index below 50 between elderly and super-elderly patients
Title of the study (Brief title) Concentration of volatile anesthetics required in the elderly
Region
Japan

Condition
Condition Diseases requiring surgical treatment
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Breast surgery Obsterics and gynecology Orthopedics
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the concentration of desflurane and sevoflurane required for maintaining bispectral index below 50 between elderly and super-elderly patients
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bispectral index during anesthesia with desflurane and sevoflurane
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To provide general anesthesia with predetermined concentration of desflurane to elderly (66-80 yr) patients and measure bispectral index
Interventions/Control_2 To provide general anesthesia with predetermined concentration of desflurane to super-elderly (>= 81 yr) patients and measure bispectral index
Interventions/Control_3 To provide general anesthesia with predetermined concentration of sevoflurane to elderly (66-80 yr) patients and measure bispectral index
Interventions/Control_4 To provide general anesthesia with predetermined concentration of sevoflurane to super-elderly (>= 81 yr) patients and measure bispectral index
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
66 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with American Society of Anesthesiologists physical status I or II
Key exclusion criteria Patients with 1) asthma, 2) arrhythmia, 3) psychiatric diseases or neuromuscular diseases 4) ischemic heart diseases or decreased cardiac function with left ventricular ejection fraction equal to or lower than 40% 5) hypotension with systolic blood pressure equal to or lower than 80 mmHg 6) Serum sodium levels equal to or lower than 135 mEq/l or equal to or higher than 148 mEq/l
Target sample size 100

Research contact person
Name of lead principal investigator Yutaka Oda
Organization Osaka City Juso Hospital
Division name Department of Anesthesiology
Address 2-12-27 Nonaka-kita, Yodogawa-ku, Osaka
TEL 06-6150-8000
Email yutakaodayutaka@gmail.com

Public contact
Name of contact person Yutaka Oda
Organization Osaka City Juso Hospital
Division name Department of Anesthesiology
Address 2-12-27 Nonaka-kita, Yodogawa-ku, Osaka
TEL 06-6150-8000
Homepage URL
Email yutakaodayutaka@gmail.com

Sponsor
Institute Osaka City Juso Hospital
Institute
Department

Funding Source
Organization Institutional funding
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 06 Month 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 31 Day
Anticipated trial start date
2018 Year 06 Month 13 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 12 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037576

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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