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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000030896 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | brain tumor which should be resected under awake craniotomy | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Nagoya university |
Institute | |
Department |
Funding Source | |
Organization | Japanese Governmental office |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035096 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |