UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037648 |
|---|---|
| Receipt number | R000042927 |
| Scientific Title | Comparison of changes in Orexin-A levels in propofol-remifentanil anesthesia with sevoflurane-remifentanil anesthesia undergoing ear surgery. |
| Date of disclosure of the study information | 2019/08/09 |
| Last modified on | 2019/08/09 12:24:50 |
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Basic information
Public title
Comparison of changes in Orexin-A levels in propofol-remifentanil anesthesia with sevoflurane-remifentanil anesthesia undergoing ear surgery.
Acronym
Comparison of changes in Orexin-A levels in propofol-remifentanil anesthesia with sevoflurane-remifentanil anesthesia undergoing ear surgery.
Scientific Title
Comparison of changes in Orexin-A levels in propofol-remifentanil anesthesia with sevoflurane-remifentanil anesthesia undergoing ear surgery.
Scientific Title:Acronym
Comparison of changes in Orexin-A levels in propofol-remifentanil anesthesia with sevoflurane-remifentanil anesthesia undergoing ear surgery.
Region
| Japan |
Condition
Condition
ear disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the plasma OXA levels in patients undergoing ear surgery with total intravenous anesthesia and inhalational aneshesia.
Basic objectives2
Others
Basic objectives -Others
To compare the emergence time from anesthesia with total intravenous anesthesia and inhalational aneshesia.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare the plasma OXA levels in patients undergoing ear surgery with total intravenous anesthesia and inhalational aneshesia.
Key secondary outcomes
To compare the emergence time from anesthesia with total intravenous anesthesia and inhalational aneshesia.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
measurement of plasma orexin-A (4 times)
Interventions/Control_2
measurement of plasma norepinephrine and epinephrine (4times)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing ear surgery at the Miyazaki University Hospital, Miyazaki, Japan between August 2015 and September 2016 were recruited. Written informed consent was obtained from all patients. Forty-seven patients with ASA physical state 1 or 2 undergoing ear surgery under total intravenous anesthesia (TIVA) or sevoflurane anesthesia (SEV) were enrolled.
Key exclusion criteria
Patients were excluded who had used analgesics, sedatives, or antidepressants within 72 h prior to surgery; had a history of obstructive sleep apnea syndrome, chronic obstructive pulmonary disease, diabetes mellitus, endocrine disorder, or neurological disease; had a hepatic, renal, or psychological disorder; whose operation time was < 2 hours or > 5 hours; were < 20 or > 70 years old, or had a BMI < 18.5 or > 25.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Shirasaka |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Department of Anesthesiology and Intensive care
Zip code
889-1692
Address
5200 Kihara Kiyotake, Miyazaki
TEL
0985-85-2970
shirasak@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Shirasaka |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Department of Anesthesiology and Intensive care
Zip code
889-1692
Address
5200 Kihara Kiyotake, Miyazaki
TEL
0985-85-2970
Homepage URL
shirasak@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive care, Faculty of Medicine, University of Miyazaki.
Institute
Department
Personal name
Funding Source
Organization
This work was funded by grant-in-aid for scientific research (No. 17K16739) from the Ministry of Education, Science and Culture in Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, University of Miyazaki
Address
5200 Kihara Kiyotake, Miyazaki, Japan
Tel
0985-85-2970
shirasak@med.miyazaki-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
| 2019 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
https://miyazaki.bvits.com/rinri/Apply/show.aspx?TYPE=0&ID=2147
Publication of results
Published
Result
URL related to results and publications
https://miyazaki.bvits.com/rinri/Apply/show.aspx?TYPE=4&ID=4205
Number of participants that the trial has enrolled
41
Results
The extubation times were faster in the TIVA group than in the SEV group. At the emergence state, plasma orexin-A increased in both the TIVA and SEV groups, as compared with their corresponding T0 levels. There were no significant differences in the plasma orexin-A values of the TIVA and SEV groups at each corresponding time point.
Results date posted
| 2019 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 31 | Day |
Baseline Characteristics
Patients undergoing ear surgery at the Miyazaki University Hospital, Miyazaki, Japan between August 2015 and September 2016 were recruited.
Participant flow
All patients left hospital safely.
Adverse events
none
Outcome measures
The TIVA group had faster extubation times than did the SEV group. Although plasma OXA increased significantly at emergence from anesthesia (T2 and T3) in both groups, no significant differences between the two groups were detected at each point. Although plasma NE increased significantly after extubation (T2 and T3) in both groups, plasma EP increased significantly after extubation (T2 and T3) only in the SEV group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042927
