UMIN-CTR Clinical Trial

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 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	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
Email	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
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)

IRB Contact (For public release)
Organization	Osaka City Juso Hospital
Address	2-12-27 Nonaka-kita, Yodogawa-ku, Osaka
Tel	0661508000
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037576