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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025833
Receipt No. 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

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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
Email 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
Email zukko@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Chubu Medical Center
(Nantan General Hospital)
Institute
Department

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
Email

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
URL(English) https://upload.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


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