UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025364 |
|---|---|
| Receipt number | 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 | 2020/05/12 15:58:03 |
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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 | Hajime |
| Middle name | |
| Last name | Ishibashi |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Anesthesiology
Zip code
271-8587
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9440
ishibashi.hajime@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Ishibashi |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Anesthesiology
Zip code
271-8587
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9440
Homepage URL
ishibashi.hajime@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
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
Nihon University School of Dentistry at Matsudo
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
Tel
047-360-9440
ishibashi.hajime@nihon-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
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
http://mol.medicalonline.jp/library/openurl/query?rft.issn=0385-0145&rft.volume=43&rft.issue=3&rft.s
Publication of results
Published
Result
URL related to results and publications
http://mol.medicalonline.jp/library/openurl/query?rft.issn=0385-0145&rft.volume=43&rft.issue=3&rft.s
Number of participants that the trial has enrolled
91
Results
Significant differences in body temperature changes were found between the NS and S group (p = 0.004). The mean skin temperature in the S group was higher than in the NS group. Mean skin temperature was significantly higher in the sevoflurane group than in the propofol group (p < 0.000).
Results date posted
| 2020 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Mean of age and gender ratio (male/female) in each groups were followed: GOS-F group(28.5, 6/11), GOS-R group (25.8, 8/9), GOS-RF group (24.7, 8/6), GOP-F(25.0, 6/6), GOP-R group (26.0, 3/10) and GOP-RF group (25.8, 8/10).
Participant flow
Total patient numbers were 91. Number of GOS-F group, GOS-R group, GOS-RF group, GOP-F group , GOP-R group, and GOP-RF group were 17, 17, 14, 12, 13 and 18.
Adverse events
no
Outcome measures
Based on the occurrence of shivering, the 91 patients were classified into a shivering (S) group (n = 22, 24.2 %) and a non-shivering (NS) group (n = 69, 75.8 %). The RF anesthesia subgroups had 19 patients in the S group and 43 in the NS group; The non-RF anesthesia subgroups had 3 patients in the S group and 26 in the NS group. Thus, shivering was significantly associated with RF anesthesia (p = 0.035).
Significant differences in body temperature changes (change from control value) were found between the NS and S group (p = 0.004). The mean skin temperature in the S group was higher than in the NS group. Mean skin temperature was significantly higher in the sevoflurane group than in the propofol group (p < 0.000).
Significant differences were found between the NS and S groups in forearm minus-fingertip skin temperature gradients (p = 0.008). Forearm minus-fingertip skin temperature gradients differed significantly between the sevoflurane and propofol- groups (p = 0.031).
No significant changes in bladder temperature were observed between the NS and S groups (p = 0.239) or between the sevoflurane and propofol groups (p = 0.379).
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
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028900
