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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033256
Receipt No. R000037912
Scientific Title The incidence of postoperative cognitive dysfunction of the elderly patients and the effect of intraoperative brain function monitoring.
Date of disclosure of the study information 2018/07/03
Last modified on 2019/06/03

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Basic information
Public title The incidence of postoperative cognitive dysfunction of the elderly patients and the effect of intraoperative brain function monitoring.
Acronym The incidence of postoperative cognitive dysfunction of the elderly patients and the effect of intraoperative brain function monitoring.
Scientific Title The incidence of postoperative cognitive dysfunction of the elderly patients and the effect of intraoperative brain function monitoring.
Scientific Title:Acronym The incidence of postoperative cognitive dysfunction of the elderly patients and the effect of intraoperative brain function monitoring.
Region
Japan

Condition
Condition malignant diseases or benign diseases
Classification by specialty
Surgery in general Gastrointestinal surgery Obsterics and gynecology
Orthopedics Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 By using brain wave monitor in addition to expired gas monitor, we will explore an optimal administration of anesthetic drugs which prevents intraoperative arousal and reduces postoperative cognitive dysfunction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between intraoperative Bispectral index values and incidence of cognitive dysfunction one week after operation.
Key secondary outcomes

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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Inpatient undergoing surgery by general anesthesia
Key exclusion criteria regional anesthesia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yamashita
Organization Kobe city medical center general hospital
Division name department of anesthesiology
Zip code
Address 2-1-1 Minatojima-minamichou chuou-ku Kobe-city
TEL 078-302-4321
Email cantateveritas@ae.auone-net.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yamashita
Organization Kobe city medical center general hospital
Division name department of anesthesiology
Zip code
Address 2-1-1 Minatojima-minamichou chuou-ku Kobe-city
TEL 078-302-4321
Homepage URL
Email cantateveritas@ae.auone-net.jp

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

Funding Source
Organization no organization
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
2018 Year 07 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 Main results already published
Date of protocol fixation
2018 Year 07 Month 03 Day
Date of IRB
2019 Year 07 Month 31 Day
Anticipated trial start date
2018 Year 07 Month 03 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information we investigate BIS values leading to optimal dose of anesthetic that minimizes postoperative cognitive dysfunction

Management information
Registered date
2018 Year 07 Month 03 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037912

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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