UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015701 |
|---|---|
| Receipt number | R000018250 |
| Scientific Title | Evaluation of serum concentration of local anesthetics after infiltration in scalp and effects of lipid emulsion infusion against local anesthetic intoxication. |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2022/05/24 05:01:58 |
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Basic information
Public title
Evaluation of serum concentration of local anesthetics after infiltration in scalp and effects of lipid emulsion infusion against local anesthetic intoxication.
Acronym
Evaluation of serum concentration of local anesthetics after infiltration in scalp
Scientific Title
Evaluation of serum concentration of local anesthetics after infiltration in scalp and effects of lipid emulsion infusion against local anesthetic intoxication.
Scientific Title:Acronym
Evaluation of serum concentration of local anesthetics after infiltration in scalp
Region
| Japan |
Condition
Condition
The patients who received brain surgery with craniotomy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is evaluating serum concentration of local anesthetics after scalp infiltration to determine safe dose of local anesthetics.
Basic objectives2
Others
Basic objectives -Others
The secondary aim of this study is evaluating the effect of lipid emulsion infusion for awaking delay after craniotomy with local anesthetic infiltration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of serum concentration of local anesthetics
Key secondary outcomes
Lipid emulsion infusion facilitates awake from anestetic status in the patient with craniotomy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo craniotomy surgery
Key exclusion criteria
The patients of their relatives do not accept Informed consent.
The patients whose ASA physical status more than 4.
The patients who are younger than 20 yo or elder than 80 yo.
The patients whose body weight is less than 40 kg.
The patients who has allergy or contraindication to the drug which may use in this study.
The patients who have renal or hepatic failure.
The patient who is received opioid preoperatively.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kamiya |
Organization
Niigata Universitu Medical and Dental Hospital
Division name
Anesthesiology
Zip code
951-8520
Address
1-754 Asahimachidori Chuo-ku, Niigata City, Japan
TEL
025-227-2328
y-kamiya@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kamiya |
Organization
Niigata Universitu Medical and Dental Hospital
Division name
Anesthesiology
Zip code
951-8520
Address
1-754 Asahimachidori Chuo-ku, Niigata City, Japan
TEL
025-227-2328
Homepage URL
y-kamiya@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata Universitu Medical and Dental Hospital
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
Niigata University Central Review Board of Clinical Research
Address
1-757 Asahimachidori Chuo-ku, Niigata City, Japan
Tel
025-368-9343
crbcr@adm.niigata-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
| 2014 | Year | 11 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intervention study
Management information
Registered date
| 2014 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018250
