UMIN-CTR Clinical Trial

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