UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042843 |
|---|---|
| Receipt number | R000048907 |
| Scientific Title | Evaluation of analgesia by electroencephalogram during general anesthesia |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2022/12/25 21:43:33 |
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Basic information
Public title
Evaluation of analgesia by electroencephalogram during general anesthesia
Acronym
Development of EEG based analgesia monitor
Scientific Title
Evaluation of analgesia by electroencephalogram during general anesthesia
Scientific Title:Acronym
Development of EEG based analgesia monitor
Region
| Japan |
Condition
Condition
Surgical patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our previous study showed that two peak heights of EEG bicoherence that were calculated by bispectral analysis were decreased after incision and recovered to the previous values after 3 mcg/kg of fentanyl administration. Here we examine whether these two peak heights can be good indicators of analgesia during surgery.
Basic objectives2
Others
Basic objectives -Others
We also observe circulatory status such as blood pressure and heart rate.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We administer fentanyl intermittently. We add some amount of fentanyl when peak heights of EEG bicoherence decrease below previously defined threshold, and compare them with those 5 minutes after fentanyl administration.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who satisfied the following all conditions.
1) age is 20 or more and less than 65
2) supine position during surgery
3) ASA-PS is I or II
4) patients who agreed after informed consent
Key exclusion criteria
patients who matched either of following conditions.
1) patients who had severe liver dysfunction or severe renal dysfunction
2) pregnant or lactating women
3) patients who had neurological disorder
4) patients who scheduled head or neck surgery
5) patients who are medicated a drug that had interaction with anesthetic or analgesic
6) patients who require legal representative
7) patients who were judged as inappropriate for the current study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hagihira |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-5-1 Shin-machi, Hirakata City
TEL
072-804-2683
hagihirs@hirakata.kmu.a.cjp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hagihira |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
072-804-2683
TEL
072-804-2683
Homepage URL
hagihirs@hirakata.kmu.a.cjp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Center for Ethical Review
Address
2-5-1 Shin-machi, Hirakata City
Tel
072-804-2440
hagihirs@hirakata.kmu.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 | 12 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
We add some amount of fentanyl when peak heights of EEG bicoherence decrease below previously defined threshold, and compare them with those 5 minutes after fentanyl administration.
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048907
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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