UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of droperidol on Bispecral index and AEP Index under general anesthesia.
Title of the study (Brief title)	The effect of droperidol on Bispecral index and AEP Index under general anesthesia.
Region	Japan

Condition
Condition	Patients undergoing general anesthesia in elective surgery.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of small dose administration of droperidol on bispectral index and AEP index during or after general anesthesia.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of bispectral index and AEP index after administration of droperidol.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Administration of droperidol during general anesthesia
Interventions/Control_2	Administration of droperidol after arousal from general anesthesia
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	Patients undergoing general anesthesia for elective surgery and ASA physical status 1 or 2
Key exclusion criteria	Patients with neurological disorders and taking antipsychotic drugs, hearing disturbance, extrapyramidal symptoms, long QT in preoperative electrocardiogram
Target sample size	40

Research contact person
Name of lead principal investigator	Mikito Kawamata
Organization	Shinshu University school of medicine
Division name	The department of anesthesiology and resuscitology
Address	3-1-1 Asahi Matsumoto city Nagano
TEL	0262-37-2670
Email	masui@shinshu-u.ac.jp

Public contact
Name of contact person	Takanobu Hirabayashi
Organization	Shinshu University school of medicine
Division name	The department of anesthesiology and resuscitology
Address	3-1-1 Asahi Matsumoto city Nagano
TEL	0262-37-2670
Homepage URL
Email	hirabayashi.ajyako@gmail.com

Sponsor
Institute	Shinshu University school of medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	信州大学医学部付属病院(長野県) Shinshu University Hospital(Nagano)

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 15 Day
Anticipated trial start date	2015 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 13 Day
Last modified on	2019 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018771