UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024269
Receipt No. R000027942
Scientific Title Preventive effects of Suvorexant on delirium at postoperative hip surgery: arandomized placebo-controlled trial
Date of disclosure of the study information 2016/10/03
Last modified on 2016/10/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Preventive effects of Suvorexant on delirium at postoperative hip surgery: arandomized placebo-controlled trial
Acronym Suvorexant prevents delirium in postoperative hip surgery
Scientific Title Preventive effects of Suvorexant on delirium at postoperative hip surgery: arandomized placebo-controlled trial
Scientific Title:Acronym Suvorexant prevents delirium in postoperative hip surgery
Region
Japan

Condition
Condition Hip surgery patiens
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether suvorexant, is effective for the prevention of delirium postoperatively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of delirium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 to recieve suvorexants
Interventions/Control_2 placebo
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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria elective hip surgery patients
Key exclusion criteria dementia
SAS
the patients not agree
severe disorder of liver function
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Anesthesiology
Zip code
Address 1-1 Kodacho, Shunan-city 7458522, Japan
TEL 0834-22-4411
Email manabu-ygc@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Anesthesiology
Zip code
Address 1-1 Kodacho, Shunan-city 7458522, Japan
TEL 0834-22-4411
Homepage URL
Email manabu-ygc@umin.ac.jp

Sponsor
Institute Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 03 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.