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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040435
Receipt No. R000043735
Scientific Title A comparison between bispectral index (BIS) and patient state index (PSI) in elderly patients under general anesthesia with propofol
Date of disclosure of the study information 2020/05/21
Last modified on 2020/05/18

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Basic information
Public title A comparison between bispectral index (BIS) and patient state index (PSI) in elderly patients under general anesthesia with propofol
Acronym A comparison between bispectral index (BIS) and patient state index (PSI) in elderly patients under general anesthesia with propofol
Scientific Title A comparison between bispectral index (BIS) and patient state index (PSI) in elderly patients under general anesthesia with propofol
Scientific Title:Acronym A comparison between bispectral index (BIS) and patient state index (PSI) in elderly patients under general anesthesia with propofol
Region
Japan

Condition
Condition head, neck and throat disease, extremities and peripheral vessel disease, disease of the chest wall, abdominal wall and perineum
Classification by specialty
Vascular surgery Endocrine surgery Breast surgery
Ophthalmology Dermatology Oto-rhino-laryngology
Orthopedics Anesthesiology Oral surgery
Plastic surgery Aesthetic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to compare the efficacy of bispectral index (BIS) and patient state index (PSI) in eldery patients scheduled general anesthesia with propofol.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the duration from discontinuation of the propofol to extubation
Key secondary outcomes the incidence of awareness with recall during anesthesia, the incidence of postoperative delirium within 7 days after the operation, and the incidence of myocardial infarction and stroke within 30 days after the operation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 The duration of intevention is from obtaining patients' concent and confirming
the eligibility criteria to 30th day after the operation.
Interventions/Control_2 The number of intervention is one.
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
120 years-old >=
Gender Male and Female
Key inclusion criteria Patients are included if they meet the following eligibility criteria: (1)65 yr old or older; (2)the expected operative duration is from 2 to 8 hours; (3)scheduled head, neck and throat surgery, extremities and peripheral vessel surgery, the chest wall, abdominal wall and perineum surgery.
Key exclusion criteria Patients are excluded if they meet the following exclusion criteria: (1)cerebral parenchyma disease, cerebrovascular
disease, myelopathy, peripheral neuropathy, myopathy, mental disorder, dementia; (2)left ventricular ejection fraction is less than 50%, heart valve disease classified moderate or severe; (3)% vital capacity is less than 80%, and/or forced expiratory volume % in 1 second is less than 70%; (4)liver disease classified Child-Pugh B or C; (5)kidney disease with estimated glomerular filtration rate less than 60 mL/min/1.73m2; (6)diabetes mellitus with HbA1c greater than or equal to 8%; (7)body mass index (BMI) is less than 18.5 or greater than or equal to 25.0; (8)scheduled epidural anesthesia and/or peripheral nerve block; (9)emergency operation.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Kaneko
Organization Yamaguchi University Faculty of Medicine and Health Sciences, Yamaguchi University Hospital
Division name the department of Anesthesiology-Resuscitology
Zip code 755-8505
Address 1-1-1, Minamikogushi, Ube City, Yamaguchi Prefecture, Japan
TEL 0836-22-2111
Email kaneshu@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Shuichi
Middle name
Last name Kaneko
Organization Yamaguchi University Faculty of Medicine and Health Sciences, Yamaguchi University Hospital
Division name the department of Anesthesiology-Resuscitology
Zip code 755-8505
Address 1-1-1, Ube City, Yamaguchi Prefecture, Japan
TEL 0836-22-2291
Homepage URL
Email kaneshu@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Faculty of Medicine and Health Sciences, Yamaguchi University Hospital, the department of Anesthesiology-Resuscitology
Institute
Department

Funding Source
Organization contribution
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 Center For Clinical Research. Yamaguchi University Hospital
Address 1-1-1, Minamikogushi, Ube City, Yamaguchi Prefecture, Japan
Tel 0836-22-2428
Email clin_res@yamaguchi-u.ac.jp

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 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 21 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 26 Day
Date of IRB
2020 Year 01 Month 30 Day
Anticipated trial start date
2020 Year 05 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 18 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043735

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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