UMIN-CTR Clinical Trial

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	2024 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	2021 Year 05 Month 07 Day

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