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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025364
Receipt No. R000028900
Scientific Title Clinical study of shivering after general anesthesia (anesthesia method and body temperature)
Date of disclosure of the study information 2017/01/10
Last modified on 2019/05/29

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Basic information
Public title Clinical study of shivering after general anesthesia (anesthesia method and body temperature)
Acronym Clinical study of shivering after general anesthesia
Scientific Title Clinical study of shivering after general anesthesia (anesthesia method and body temperature)
Scientific Title:Acronym Clinical study of shivering after general anesthesia
Region
Japan

Condition
Condition jaw deformity
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We study that anesthesia method and the change of body temperature relate to frequency of shivering.
Basic objectives2 Others
Basic objectives -Others We study prophylaxis of shivering
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We measure the frequency of shivering after general anesthesia.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oxygen, laughing gas, sevoflurane, remifentanil
Interventions/Control_2 oxygen, laughing gas, sevoflurane, remifentanil, fentanil
Interventions/Control_3 oxygen, laughing gas, sevoflurane, fentanil
Interventions/Control_4 oxygen, laughing gas, propofol, remifentanil
Interventions/Control_5 oxygen, laughing gas, propofol, remifentanil, fentanil
Interventions/Control_6 oxygen, laughing gas, propofol, fentanil
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria patients with jaw deformity operated lower jawbone osteotomy
Key exclusion criteria patients with jaw deformity operated lower and upper jawbone osteotomy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Ishibashi
Organization Nihon University School of Dentistry at Matsudo
Division name Department of Anesthesiology
Zip code
Address 2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL 047-360-9440
Email ishibashi.hajime@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Ishibashi
Organization Nihon University School of Dentistry at Matsudo
Division name Department of Anesthesiology
Zip code
Address 2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL 047-360-9440
Homepage URL
Email ishibashi.hajime@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

Funding Source
Organization Nihon 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 日本大学松戸歯学部付属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 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
2016 Year 12 Month 20 Day
Date of IRB
2016 Year 10 Month 16 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 22 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028900

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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