UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the influence of antiemetic drugs on the electroencephalogram during anesthesia
Title of the study (Brief title)	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	Kazuko Hayashi
Organization	Kyoto Chubu Medical Center (Nantan General Hospital)
Division name	Anesthesiology
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	Kazuko Hayashi
Organization	Kyoto Chubu Medical Center (Nantan General Hospital)
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029532