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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014648
Receipt No. R000017041
Scientific Title Type of infusion affects blood electrolyte and glucose during general anesthesia in pediatrics
Date of disclosure of the study information 2014/07/25
Last modified on 2018/12/06

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Basic information
Public title Type of infusion affects blood electrolyte and glucose during general anesthesia in pediatrics
Acronym Type of infusion affects blood electrolyte and glucose during general anesthesia in pediatrics
Scientific Title Type of infusion affects blood electrolyte and glucose during general anesthesia in pediatrics
Scientific Title:Acronym Type of infusion affects blood electrolyte and glucose during general anesthesia in pediatrics
Region
Japan

Condition
Condition pediatric in aneshtesia
Classification by specialty
Surgery in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we compared blood electrolyte balance and blood glucose level with the use of hypotonic versus isotonic fluids.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The intraoperative measurement
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
0 years-old <=
Age-upper limit
7 years-old >
Gender Male and Female
Key inclusion criteria undergoing oro-maxillofacial surgery and dental treatment under general anesthesia
Key exclusion criteria The patient that it was not obtained its consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Ouchi
Organization kagoshima university
Division name Anesthesia center
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL 099-275-5111
Email ken2006anes@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro OUCHI
Organization Kagoshima University
Division name Anesthesia center
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL 099-275-5111
Homepage URL
Email ken2006anes@yahoo.co.jp

Sponsor
Institute kagoshima university
Institute
Department

Funding Source
Organization kagoshima university
Organization
Division
Category of Funding Organization Other
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
2014 Year 07 Month 25 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 No longer recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 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 we compared blood sodium, potassium and glucose levels in the preoperative and intraoperative periods

Management information
Registered date
2014 Year 07 Month 25 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017041

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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