UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009555 |
|---|---|
| Receipt number | R000009875 |
| Scientific Title | Ambient temperature affected body temparature during general anesthesia. |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2013/09/02 08:42:20 |
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Basic information
Public title
Ambient temperature affected body temparature during general anesthesia.
Acronym
Ambient temperature affected body temparature during general anesthesia.
Scientific Title
Ambient temperature affected body temparature during general anesthesia.
Scientific Title:Acronym
Ambient temperature affected body temparature during general anesthesia.
Region
| Japan |
Condition
Condition
gallbladder calculosis
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Prevent redistribution hypothermia during general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Warm operating room could prevent redistribution hypothermia during general anesthesia or not.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
maintaining operating room temperature almost 24 degrees.
Interventions/Control_2
maintaining operating room temperature almost 25 degrees.
Interventions/Control_3
maintaining operating room temperature almost 26 degrees.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study enrolled patients (ASA physical status 1 to 2) scheduled for undergoing laparoscopic cholecystectomy under general anesthesia. .
Key exclusion criteria
severe cardiovascular disease
metabolic disorders
fever with active infectious source
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Suzuki |
Organization
Uwajima city hospital
Division name
Department of Anesthesia
Zip code
Address
1-1 Goten-machi, Uwajima, Ehime 798-8510, Japan
TEL
0895-25-1111
ysuzuki1978@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YASUYKI SUZUKI |
Organization
Uwajima city hospital
Division name
Department of Anesthesia
Zip code
Address
0895-25-1111
TEL
0895-25-1111
Homepage URL
ysuzuki1978@gmail.com
Sponsor or person
Institute
Department of Anesthesia, Uwajima City Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2012 | Year | 12 | Month | 15 | 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
| 2011 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 15 | Day |
Last modified on
| 2013 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009875
