UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the aggravation prophylaxis of postoperative delirium for the elderly
Title of the study (Brief title)	A study on the aggravation prophylaxis of postoperative delirium for the elderly
Region	Japan

Condition
Condition	postoperative delirium
Classification by specialty	Surgery in general Psychiatry Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this RCT study is to make it clear whether Haloperidol administration from an early stage of delirium is useful for the aggravation prevention of postoperative delirium of the elderly persons more than 75 years old.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We chase psychological disorders / abnormal behavior assessment with NEECHAM score from preoperative day to postoperative day 10 consecutively.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In the intervention group, Haloperidol 5mg intravenous drip infusion will be performed from postoperative day 0 to 5, when the NEECHAM score is 20 to 24. When the NEECHAM score is less than 19, conventional treatment of delirium including the haloperidol intravenous drip infusion will be performed.
Interventions/Control_2	Only serial obsevations will be applied to the control group. When the NEECHAM score is less than 19, conventional treatment of delirium including the haloperidol intravenous drip infusion will be performed.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	75 years or older patients with abdominal surgery / orthopedic surgery are distributed to the intervention / non-intervention group.
Key exclusion criteria	A patient with emergency surgery. The case whose NEECHAM score is less than 19.
Target sample size	180

Research contact person
Name of lead principal investigator	Shinji Fukata
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Perioperative Medical Care
Address	Gengo 35, Morioka-cho, Obu-city, Aichi, Japan
TEL	0562-46-2311
Email	fukatash@ncgg.go.jp

Public contact
Name of contact person	Shinji Fukata
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Perioperative Medical Care
Address	Gengo 35, Morioka-cho, Obu-city, Aichi, Japan
TEL	0562-46-2311
Homepage URL
Email	fukatash@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology(Independent administative agency)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2012 Year 02 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 31 Day
Anticipated trial start date	2012 Year 02 Month 01 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	2012 Year 02 Month 02 Day
Last modified on	2016 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008480