UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042089 |
|---|---|
| Receipt number | R000047945 |
| Scientific Title | Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia |
| Date of disclosure of the study information | 2020/10/12 |
| Last modified on | 2022/04/03 08:16:36 |
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Basic information
Public title
Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Acronym
Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Scientific Title
Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Scientific Title:Acronym
Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Region
| Japan |
Condition
Condition
Patients undergoing surgery with general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of anesthetics on electroencephalogram(EEG) is very. The effect is depending on type of anesthetics. For example, sevoflurane, an inhaled anesthetics, increases proportion of EEG alpha wave compared to propofol, an intravenous anesthetics. This study aims to investigate effect of desflurane, another inhaled anesthetics, and propofol on frequency distribution of EEG.
Basic objectives2
Others
Basic objectives -Others
Some patient develop delirium after surgery with general anesthesia. Among various causative factor, anesthetics itself could be responsible for development of the delirium. We hypothesized analysis of character of EEG frequency proportion by various anesthetics could predict potency of delirium development.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in EEG frequency distribution between desflurane and propofol from the introduction of general anesthesia to the start of surgery
Key secondary outcomes
Perioperative psychiatric and general physio-pathological condition including liver, kidney etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Desflurane
Interventions/Control_2
Propofol
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery with general anesthesia
Key exclusion criteria
Patients with skin lesions on the forehead, where the BIS monitor is attached, neurosurgery, patients with cerebrovascular complications, patients with psychiatric disorders, patients with opioid addiction
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kushikata |
Organization
Hirosaki University Graduate School of Medicine
Division name
Anesthesiology
Zip code
036-8562
Address
Aomori Prefecture, Hirosaki City, 5 Zaifucho
TEL
0172-33-5111
tetsuyak@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kushikata |
Organization
Hirosaki University Graduate School of Medicine
Division name
Anesthesiology
Zip code
036-8562
Address
Aomori Prefecture, Hirosaki City, 5 Zaifucho
TEL
0172-33-5111
Homepage URL
tetsuyak@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Hirosaki University Graduate School of Medicine
Address
Aomori Prefecture, Hirosaki City, 5 Zaifucho
Tel
0172-33-5111
tetsuyak@hirosaki-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 12 | 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
| 2020 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2025 | 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 | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047945
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
