UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012371 |
|---|---|
| Receipt number | R000014441 |
| Scientific Title | Effects of thoracic epidural anesthesia on spinal tracts |
| Date of disclosure of the study information | 2013/11/21 |
| Last modified on | 2014/12/01 19:55:31 |
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Basic information
Public title
Effects of thoracic epidural anesthesia on spinal tracts
Acronym
Effects of thoracic epidural anesthesia on spinal tracts
Scientific Title
Effects of thoracic epidural anesthesia on spinal tracts
Scientific Title:Acronym
Effects of thoracic epidural anesthesia on spinal tracts
Region
| Japan |
Condition
Condition
Adult elective lung surgery patients undergoing general anesthesia and thoracic epidural anesthesia
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of thoracic epidural anesthesia on spinal tracts functions using the examination of somatosensory evoked potentials and motor evoked potentials in a lower extremity.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent changes in the amplitude of motor evoked potentials in a lower extremity at 60 minutes after the epidural ropivacaine administration.
Key secondary outcomes
1)Percent changes in the amplitudes of motor evoked potentials in lower extremities at 15, 30, 45, 90, 120, 150 and 180 minutes after the epidural ropivacaine administration.
2)Percent changes in the amplitudes of somatosensory evoked potentials in lower extremities after the epidural ropivacaine administration.
3)Percent changes in the latency of motor evoked potentials in lower extremities after the epidural ropivacaine administration.
4)Percent changes in the latency of somatosensory evoked potentials in lower extremities after the epidural ropivacaine administration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.2% ropivacaine 10ml grou
Interventions/Control_2
0.375% ropivacaine 10ml group
Interventions/Control_3
0.75% ropivacaine 10ml group
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
Adult elective lung surgery patients undergoing general anesthesia and thoracic epidural anesthesia
Key exclusion criteria
1)Neuromuscular diseases
2)Remarkable neurological symptoms
3)Contraindications for epidural anesthesia
4)History of Allergy to ropivacaine or drugs on the protocol
5)Estimated the trial entry inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Tobita |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-757, Asahimati-dori, chuo-ku, Niigata
TEL
025-227-2328
zz-top@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Tobita |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-757, Asahimati-dori, chuo-ku, Niigata
TEL
025-227-2328
Homepage URL
zz-top@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2013 | Year | 11 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 21 | 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
| 2013 | Year | 11 | Month | 21 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014441
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
