UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040065 |
|---|---|
| Receipt number | R000045674 |
| Scientific Title | Effects of pre-warming during epidural combined general anesthesia on body temperature reduction by induction of anesthesia |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2022/07/14 18:26:51 |
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Basic information
Public title
Effects of pre-warming during epidural combined general anesthesia on body temperature reduction by induction of anesthesia
Acronym
Effects of pre-warming on body temperature reduction by induction of anesthesia
Scientific Title
Effects of pre-warming during epidural combined general anesthesia on body temperature reduction by induction of anesthesia
Scientific Title:Acronym
Effects of pre-warming on body temperature reduction by induction of anesthesia
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic surgery in the supine position under general anesthesia combined with an epidural
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the timing of initiation of a forced air warming device can prevent a decrease in central temperature in patients undergoing surgery under general anesthesia combined with epidural.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of temperature and body temperature change between the two groups from the time of admission to the end of surgery will be compared.
Key secondary outcomes
Comparison of the presence or absence of shivering and surgical site infection (e.g., redness and wound separation) between the two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Forced air warming equipment started immediately after entering the operating room.
Interventions/Control_2
Forced air warming equipment started just before starting surgery.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients in waiting laparoscopic surgery
2. general anesthesia combined with epidural
3. over 20 years old
4. the surgical position is supine
5. patients who have given written consent
Key exclusion criteria
1. inadequate data (e.g., medical records)
2. patients who are deemed unsuitable to participate in the study due to other serious complications
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | kazuhiro |
| Middle name | |
| Last name | shirozu |
Organization
Kyushu University Hospital
Division name
Anesthesia and critical care medicine
Zip code
814-0001
Address
3-1-1 maidashi, higashi-ku, Fukuoka
TEL
092-642-5714
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | kazuhiro |
| Middle name | |
| Last name | shirozu |
Organization
Kyushu University Hospital
Division name
Anesthesia and critical care medicine
Zip code
814-0001
Address
3-1-1 maidashi, higashi-ku, Fukuoka
TEL
092-642-5714
Homepage URL
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
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
Center for Clinical and Translational Research(CCTR)
Address
3-1-1 maidashi, higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2020 | Year | 04 | 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
120
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
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045674
