UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030520 |
|---|---|
| Receipt number | R000033479 |
| Scientific Title | The concentration of local anesthetics required for neural block under general anesthesia |
| Date of disclosure of the study information | 2017/12/22 |
| Last modified on | 2017/12/22 13:45:05 |
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Basic information
Public title
The concentration of local anesthetics required for neural block under general anesthesia
Acronym
The concentration of local anesthetics required for neural block under general anesthesia
Scientific Title
The concentration of local anesthetics required for neural block under general anesthesia
Scientific Title:Acronym
The concentration of local anesthetics required for neural block under general anesthesia
Region
| Japan |
Condition
Condition
inguinal hernia surgery, undescended testes surgery, abdominal surgery, limb surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the 50% effective concentration (EC50) and the 95% effective concentration (EC95) of local anesthetics for neural block under general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EC95 and EC50 of local anesthetics (levobupivacaine) for neural block (ultrasound-guided ilioinguinal/iliohypogastric nerve block) under general anesthesia (2% inhaled anesthetic sevoflurane)
Key secondary outcomes
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
| 1 | months-old | <= |
Age-upper limit
| 75 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients (ASA PS 1-2) undergoing scheduled surgery (inguinal hernia repair and undescended testes surgery)
Key exclusion criteria
Neurologic, neuromuscular, psychiatric, seizure, or blood clotting disorders, or allergy to amide local anesthetics
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ishitsuka Shunsuke |
Organization
University of Tsukuba
Division name
Department of Anesthesiology
Zip code
Address
Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL
09045060730
dqxmw998@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ishitsuka Shunsuke |
Organization
University of Tsukuba
Division name
Department of Anesthesiology
Zip code
Address
Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL
09045060730
Homepage URL
dqxmw998@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Local Government
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 | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033479
