UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030896 |
|---|---|
| Receipt number | R000035096 |
| Scientific Title | Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine |
| Date of disclosure of the study information | 2018/01/22 |
| Last modified on | 2018/07/22 11:59:43 |
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Basic information
Public title
Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine
Acronym
Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine
Scientific Title
Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine
Scientific Title:Acronym
Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine
Region
| Japan |
Condition
Condition
brain tumor which should be resected under awake craniotomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In awake craniotomy.measurement serum concentration of ropivacaine after scalp block and local injection(haedpin area, surgical incision area) ,and evaluate appropriate ropivacaine concentration and pain control.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of serum concentration of ropivacaine(at arterial blood),
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We are going to use ropivacaine for local anesthesia upper 3.6mg/kg at awake craniotomy,and measure of serum concentration of ropivacaine(arterial blood) 15minites after injection
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are going to have the awake craniotomy at Nagoya university hospital.
1)Age 18yo to 70yo
2)ASA PS 1,2,3
3)Patient who agreed this research by informed consent and the document
Key exclusion criteria
1)Patients who don't agreed.
2)have a liver disfunction.
3)have a allergy for the ropivacaine and other local anesthetics.
4)have a disfunction of anticoagulants
5)have a severe respiratory disorder.
6)have a heart failure.
7)Other factor which patients can't be in candidate at
this study decided by the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishiwaki Kimitoshi |
Organization
Nagoya university graduate school of medicine
Division name
Department of anesthesiology
Zip code
Address
65 Tsurumaicho showa-ku nagoya city Aichi japan
TEL
052-744-2341
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sato Takehito |
Organization
Nagoya university graduate school of medicine
Division name
Department of anesthesiology
Zip code
Address
65 Tsurumaicho showa-ku nagoya city Aichi japan
TEL
052-744-2341
Homepage URL
takesato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Japanese Governmental office
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 01 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 07 | 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
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035096
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
