UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022349 |
|---|---|
| Receipt number | R000025617 |
| Scientific Title | The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2017/11/27 19:45:29 |
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Basic information
Public title
The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential
Acronym
Effect of bolus administration of ketamine on motor evoked potential
Scientific Title
The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential
Scientific Title:Acronym
Effect of bolus administration of ketamine on motor evoked potential
Region
| Japan |
Condition
Condition
adolescent idiopathic scoliosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the effect of bolus administration of ketamine on motor-evoked potential
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Minimum value of amplitude of motor-evoked potential during 10 minites after bolus administration of ketamine
Key secondary outcomes
latency of motor evoked potential
differences between each muscles
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
intravenous administration of ketamine
dose: 1 mg/kg (0.1 ml/kg)
before surgery
Interventions/Control_2
intravenous administration of saline
dose: 0.1 ml/kg
before surgery
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
Adolescent idiopathic scoliosis females who undergo posterior spinal fusion
Key exclusion criteria
gender:male
age: less than 11 or more than 19 years old
neurological abnormality
congenital scolisis
contraindication of ketamine
predicted difficult airway
allergy for drugs
patients who cannot speak Japanese
patients who do not or cannot consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenta Furutani |
Organization
Niigata University
Division name
Anesthesiology
Zip code
Address
1-757, Asahimachi-Dori, Chuo-ku, Niigata
TEL
025-227-2328
kenta-f@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Furutani |
Organization
Niigata University Medical and Dental Sciences
Division name
Anesthesiology
Zip code
Address
1-757, Asahimachi-Dori, Chuo-ku
TEL
025-227-2328
Homepage URL
kenta-f@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 20 | 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
| 2016 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | 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
| 2016 | Year | 05 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025617
