UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027317 |
|---|---|
| Receipt number | R000031297 |
| Scientific Title | An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy |
| Date of disclosure of the study information | 2017/05/12 |
| Last modified on | 2018/05/21 18:10:55 |
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Basic information
Public title
An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Acronym
An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Scientific Title
An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Scientific Title:Acronym
An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Region
| Japan |
Condition
Condition
Diseases on nurosurgery undergoing awake craniotomy
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Both scalp block and local infiltration anesthesia are very important for pain relief during awake craniotomy, and therefore we must ensure success and safety when performing these techniques. In awake craniotomy guidelines in Japan, long acting drugs such as ropivacaine and levobupivacaine are recommended. However, the relationships of a given dose with serum concentration and local anesthetic toxicity are not clear. In this study, we administrated levobupivacaine for scalp block and local infiltration anesthesia, and we evaluated the safety of local anesthesia by measuring the serum concentration of levobupivacaine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New method got from this research is safe for awake craniotomy.
Key secondary outcomes
Evaluation of serum concentration with pharmacokinetic/phamacodynamic model which was already published by calculating MDPE/MDAPE.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients classified as ASA-PS class I or II undergoing awake craniotomy
Key exclusion criteria
Patients with anemia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Yamakage |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
291, Minami 1 Nishi 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahito Omote |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
291, Minami 1 Nishi 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
omote@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University(Self funding)
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
| 2017 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
After induction of general anesthesia, performing a scalp block, blood samples are collected frequently, serum concentrations of anesthetic durgs are mesured by by high-performance liquid chromatography (HPLC).
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031297
