UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042843
Receipt No. R000048907
Scientific Title Evaluation of analgesia by electroencephalogram during general anesthesia
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hagihirs@hirakata.kmu.a.cjp

Sponsor
Institute Kansai Medical University
Institute
Department

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
Email 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 Open public 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
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2020 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.