UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056294 |
|---|---|
| Receipt number | R000055727 |
| Scientific Title | How intraoperative Electroencephalogram changes with different sedatives used during general anesthesia. |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2025/09/17 13:45:44 |
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Basic information
Public title
How intraoperative Electroencephalogram changes with different sedatives used during general anesthesia.
Acronym
Effects of sedative drugs on the EEG.
Scientific Title
How intraoperative Electroencephalogram changes with different sedatives used during general anesthesia.
Scientific Title:Acronym
Effects of sedative drugs on the EEG.
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to record and analyze the electroencephalogram (EEG) during general anesthesia for propofol and sevoflurane, sedative drugs widely used during general anesthesia, and to compare their components.
Basic objectives2
Others
Basic objectives -Others
Postoperative delirium is one of the common complications in postoperative patients, which not only decreases QOL and ADL but also worsens mortality, but there is currently no effective prevention or treatment. The mechanisms of EEG during general anesthesia are still largely unknown, and further development is expected in this field. The purpose of this study is to clarify the characteristics of the electroencephalogram (EEG) of propofol and sevoflurane, sedative drugs widely used during general anesthesia, by recording and analyzing the EEG during general anesthesia and comparing its components. Our future goal is to estimate the effects of sedative drugs on postoperative brain function and to find an anesthesia method that is less prone to delirium.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in Alpha wave power in intraoperative EEG with propofol and sevoflurane
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Anesthesia will be started with sevoflurane, and the sedation method will be switched to propofol intraoperatively. An EEG will be recorded for 20 minutes during each sedation. EEG recordings after the switch will be performed after a 30-minute interval after the sevoflurane expiratory concentration reaches 0%.
Interventions/Control_2
Anesthesia is initiated with propofol, and the sedation method is switched to sevoflurane intraoperatively. An EEG will be recorded for 20 minutes during each sedation. EEG recordings after the switch will be performed after the effective effect site concentration of propofol is less than 0.2 microgram/ml.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are at least 18 years of age and scheduled to undergo scheduled surgery, with a scheduled surgery time of at least 5 hours.
Key exclusion criteria
Patients with an American Society of Anesthesiologists physical status (ASA-PS) score of 3 or higher
Emergency surgery
Patients with preoperative cognitive dysfunction Patients taking antipsychotic medications
Patients with drug or alcohol dependence
Patients with a history of cerebral infarction, cerebral hemorrhage, or neurosurgery
Patients who cannot have an EEG monitor placed on the forehead due to trauma or skin disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | hideki |
| Middle name | |
| Last name | iwata |
Organization
kochi medical school
Division name
department of anesthesiology and intensive care medicine
Zip code
783-8505
Address
185-1 Okocho kohasu, Nankoku City, Kochi Prefecture, Japan
TEL
088-880-2471
iwata_hideki@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | hideki |
| Middle name | |
| Last name | iwata |
Organization
kochi medical school
Division name
department of anesthesiology and intensive care medicine
Zip code
783-8505
Address
185-1 Okocho kohasu, Nankoku City, Kochi Prefecture, Japan
TEL
088-880-2471
Homepage URL
iwata_hideki@kochi-u.ac.jp
Sponsor or person
Institute
Kochi university
Institute
Department
Personal name
Funding Source
Organization
kochi medical school
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
kochi medical school
Address
185-1 Okocho kohasu, Nankoku City, Kochi Prefecture, Japan
Tel
088-880-2180
rinri21@kochi-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
| 2024 | Year | 11 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055727
