UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032960 |
|---|---|
| Receipt number | R000037576 |
| Scientific Title | 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 | 2021/12/14 16:43:13 |
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Basic information
Public title
Comparison of the minimum alveolar concentrations of desflurane and sevoflurane required for maintaining bispectral index below 50 between elderly and super-elderly patients
Acronym
Concentration of volatile anesthetics required in the elderly
Scientific Title
Comparison of the minimum alveolar concentrations of desflurane and sevoflurane required for maintaining bispectral index below 50 between elderly and super-elderly patients
Scientific Title:Acronym
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 | Obstetrics 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
| 1st name | Yutaka |
| Middle name | |
| Last name | Oda |
Organization
Osaka City Juso Hospital
Division name
Department of Anesthesiology
Zip code
532-0034
Address
2-12-27 Nonaka-kita, Yodogawa-ku, Osaka
TEL
06-6150-8000
yutakaodayutaka@gmail.com
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Oda |
Organization
Osaka City Juso Hospital
Division name
Department of Anesthesiology
Zip code
532-0034
Address
2-12-27 Nonaka-kita, Yodogawa-ku, Osaka
TEL
06-6150-8000
Homepage URL
yutakaodayutaka@gmail.com
Sponsor or person
Institute
Osaka City Juso Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Osaka City Juso Hospital
Address
2-12-27 Nonaka-kita, Yodogawa-ku, Osaka
Tel
0661508000
yutakaodayutaka@gmail.com
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Conentrations of both desflurane and sevoflurane for maintaining bispectral index below 50 were significantly lower in patients > 80 yr than those between 66 and 80 yr.
Results date posted
| 2020 | Year | 06 | Month | 13 | Day |
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
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037576
