UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040435 |
|---|---|
| Receipt number | 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 | 2021/05/07 13:35:55 |
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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
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
kaneshu@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Faculty of Medicine and Health Sciences, Yamaguchi University Hospital, the department of Anesthesiology-Resuscitology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043735
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