UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017398 |
|---|---|
| Receipt number | R000019447 |
| Scientific Title | Independent risk factors for postoperative shivering after laparoscopic surgery |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2019/11/04 23:12:21 |
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Basic information
Public title
Independent risk factors for postoperative shivering after laparoscopic surgery
Acronym
Risk factors for postoperative shivering
Scientific Title
Independent risk factors for postoperative shivering after laparoscopic surgery
Scientific Title:Acronym
Risk factors for postoperative shivering
Region
| Japan |
Condition
Condition
laparoscopic suregery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Is postoperative shivering maked by warming method?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient temparature, shivering
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
warm patients by warm air
Interventions/Control_2
warm patients by blanket and mattress
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
laparoscopic suregry patients
Key exclusion criteria
BMI<30
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University school of medicine
Division name
Deprtment of anesthesiology and pain mediine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
ds0226@fsinet.or.jp
Public contact
Name of contact person
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University school of medicine
Division name
Deprtment of anesthesiology and pain mediine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
ds0226@fsinet.or.jp
Sponsor or person
Institute
Deprtment of anesthesiology and pain mediine
Institute
Department
Personal name
Funding Source
Organization
Deprtment of anesthesiology and pain mediine
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
Ethics Committee of Juntendo University Hospital.
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
juntencrc@juntendo.ac.jp
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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019447
