UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025833 |
|---|---|
| Receipt number | R000029532 |
| Scientific Title | Study of the influence of antiemetic drugs on the electroencephalogram during anesthesia |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2019/01/28 10:51:05 |
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Basic information
Public title
Study of the influence of antiemetic drugs on the electroencephalogram during anesthesia
Acronym
Study of the influence of antiemetic drugs on the electroencephalogram during anesthesia
Scientific Title
Study of the influence of antiemetic drugs on the electroencephalogram during anesthesia
Scientific Title:Acronym
Study of the influence of antiemetic drugs on the electroencephalogram during anesthesia
Region
| Japan |
Condition
Condition
Adult patients who were scheduled to undergo noncranial surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of antiemetic drugs on anesthesia depth by electroencephalogram monitor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram analysis before administration of antiemetic drug
Electroencephalogram analysis 1-12 minutes after administration of antiemetic drug
Key secondary outcomes
Anesthesia depth analysis before administration of antiemetic drug (BIS monitor)
Anesthesia depth analysis 1-12 minutes after administration of antiemetic drug (BIS monitor)
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
Adult patients who were scheduled to undergo non-cranial surgery.
Key exclusion criteria
QT prolongation
Neurologic or psychiatric disease.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuko Hayashi |
Organization
Kyoto Chubu Medical Center
(Nantan General Hospital)
Division name
Anesthesiology
Zip code
Address
yagi ueno 25, nantan city, kyoto, JAPAN
TEL
0771-42-2510
zukko@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Hayashi |
Organization
Kyoto Chubu Medical Center (Nantan General Hospital)
Division name
Anesthesiology
Zip code
Address
yagi ueno 25, nantan city, kyoto, JAPAN
TEL
0771-42-2510
Homepage URL
zukko@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Chubu Medical Center
(Nantan General Hospital)
Institute
Department
Personal name
Funding Source
Organization
Grants in aid for scientific research (Japan society for the promotion of scientific research)
Organization
Division
Category of Funding Organization
Other
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 | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 28 | Day |
Other
Other related information
observational study
(Measurements)
Electroencephalogram analysis before and after administration of antiemetic drug
(spectral analysis, bicoherence analysis, Poincare plot analysis)
Anesthesia depth related parameters before and after administration of antiemetic drug(BIS, SEF etc)
Hemodynamic parameters (BP, HR etc)
Respiratory parameters (RR, ETCO2 etc)
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029532
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
