UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020966 |
|---|---|
| Receipt number | R000024190 |
| Scientific Title | Plasma orexin levels at the emergence of anesthesia and the incidence of post-anesthetic shivering |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2016/02/22 13:25:24 |
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Basic information
Public title
Plasma orexin levels at the emergence of anesthesia and the incidence of post-anesthetic shivering
Acronym
Post-anesthetic shivering and orexin
Scientific Title
Plasma orexin levels at the emergence of anesthesia and the incidence of post-anesthetic shivering
Scientific Title:Acronym
Post-anesthetic shivering and orexin
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia with arterial line
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlation between the incidence of post-anesthetic shivering and plasma levels of orexin at the emergence of anesthesia.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of shivering, plasma orexin levels, and body temperature during anesthesia
Key secondary outcomes
Plasma levels of leptin, adiponectin, and gherkin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
measurement of plasma orexin level
1. induction of anesthesia, 2. start of surgery 3. end of surgery, 4. end of anesthesia
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients older than 20 years old undergoing general anesthesia with arterial line
Key exclusion criteria
Patients with ASA>3
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kanmura |
Organization
Kagoshima University Hospital
Division name
Department of anesthesiology
Zip code
Address
8-35-1 Sakuragaoka Kagoshima
TEL
099-275-5430
hase-mai@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Hasegawa-Moriyama |
Organization
Kagoshima University Hospital
Division name
Department of anesthesiology
Zip code
Address
8-35-1 Sakuragaoka Kagoshima
TEL
099-275-5430
Homepage URL
hase-mai@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
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
| 2016 | Year | 02 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024190
