UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031116 |
|---|---|
| Receipt number | R000035533 |
| Scientific Title | Comparison of the effect of desflurane and sevoflurane on postoperative circadian rhthm in patients undergoing total knee arthroplasty |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2021/02/04 12:59:42 |
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Basic information
Public title
Comparison of the effect of desflurane and sevoflurane on postoperative circadian rhthm in patients undergoing total knee arthroplasty
Acronym
Effect of anesthetics on postoperative circadian rhythm
Scientific Title
Comparison of the effect of desflurane and sevoflurane on postoperative circadian rhthm in patients undergoing total knee arthroplasty
Scientific Title:Acronym
Effect of anesthetics on postoperative circadian rhythm
Region
| Japan |
Condition
Condition
patients undergoing total knee arthroplasty
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effedts of sevoflurane and desflurane on salivary melatonin and circadian rhythm in patients undergoing total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circadian rhythm of melatonin
Key secondary outcomes
postoperative sleep disturbance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sevoflurane
Interventions/Control_2
desflurane
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing total knee arthroplasty
Key exclusion criteria
Above ASA PW3, cardiac disease, diabetes mellitus, Sjogren's syndrome, sialolithiasis disease, salivary gland tumor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Fujiwara |
Organization
Aichi Medical University Hospital
Division name
Department of Anesthesia
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
+81561623311
yyoshiff@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Komatsu |
Organization
Aichi Medical University
Division name
Department of aneshtesia
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
+81561623311
Homepage URL
komatsu-t@umin.ac.jp
Sponsor or person
Institute
University Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University Hospital
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
| 2018 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035533
