UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037648
Receipt No. 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 (Ver. 1)

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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
Email 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
Email shirasak@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Intensive care, Faculty of Medicine, University of Miyazaki.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042927