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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016189
Receipt No. R000018788
Scientific Title The influence of glucose load on metabolism using remifentanil-induced anesthesia for elderly patients
Date of disclosure of the study information 2015/01/13
Last modified on 2018/06/27

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Basic information
Public title The influence of glucose load on metabolism using remifentanil-induced anesthesia for elderly patients
Acronym The influence of glucose load on metabolism using remifentanil-induced anesthesia for elderly patients
Scientific Title The influence of glucose load on metabolism using remifentanil-induced anesthesia for elderly patients
Scientific Title:Acronym The influence of glucose load on metabolism using remifentanil-induced anesthesia for elderly patients
Region
Japan

Condition
Condition elderly patients scheduled for surgery of body surface under general anesthesia
Classification by specialty
Ophthalmology Oto-rhino-laryngology Orthopedics
Urology Anesthesiology Plastic surgery
Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of glucose load on metabolism of elderly patients scheduled for surgery of body surface.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood concentration of total ketone body, the ratio of blood concentration of ketone body
Blood concentration of free fatty acid
Blood concentration of 3-methylhistidine
Blood concentration of creatinine
Blood concentration of glucose
Blood concentration of insulin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Infuse only bicarbonate Ringer's solution during general anesthesia
Interventions/Control_2 Infuse bicarbonate Ringer's solution and a small mount of glucose during general anesthesia
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
75 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria eldely patients scheduled for surgery of body surface under general anesthesia
Key exclusion criteria ASA physical status >=3
diabetics, neurologic disease, thyroid disease, renal disorder, liver disorder, emaciation(BMI<=17), obesity(BMI>=30), patients taking steroids
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Niki
Organization Tokushima University Hospital
Division name Department of Anesthesiology
Zip code
Address 2-50-1, Kuramoto Town, Tokushima City, Tokushima, Japan
TEL 088-633-7181
Email norikokambe@tokushima-u.ec.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Niki
Organization Tokushima University Hospital
Division name Department of Anesthesiology
Zip code
Address 2-50-1, Kuramoto Town, Tokushima City, Tokushima, Japan
TEL 088-633-7181
Homepage URL
Email norikokambe@tokushima-u.ec.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Tokushima University Faculty of medicine, Department of Anesthesiology
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
Email

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
2015 Year 01 Month 13 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
Results
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
2015 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 12 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018788

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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