UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027628 |
|---|---|
| Receipt number | R000031656 |
| Scientific Title | Prospective evaluation of patient state index using different versions of Sedline |
| Date of disclosure of the study information | 2017/06/05 |
| Last modified on | 2021/11/29 08:22:42 |
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Basic information
Public title
Prospective evaluation of patient state index using different versions of Sedline
Acronym
Patient state index in different versions of SedLine
Scientific Title
Prospective evaluation of patient state index using different versions of Sedline
Scientific Title:Acronym
Patient state index in different versions of SedLine
Region
| Japan |
Condition
Condition
Unspecified diseases which require general anesthesia during surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the difference in patient state index values between different versions of SedLine
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the duration in which PSI values > 50 between different versions of SedLine when anesthesia is titrated so that BIS values around 50
Key secondary outcomes
PSI and BIS values, degree of sedation, and EEG waveforms at that time.
Patient's basic information (age, height, weight, gender, ASA; anesthesia risk classification according to the patient's health condition, and the nature of surgery)
Patient complications (history and treatment of hypertension, diabetes mellitus, chronic renal failure, and ischemic heart disease)
The following time-varying data will be recorded in the anesthesia chart or on the equipment used throughout the anesthesia management. Transcribe or download after completion.
Exhaled inhalant anesthetic concentration, heart rate, blood pressure, blood oxygen saturation (SpO2), body temperature, partial pressure of exhaled carbon dioxide, heart rate variability, perfusion index, SR/SUP (an index reflecting the suppression of EEG by deep anesthesia), EMG (an index reflecting the degree of EMG mixed with EEG), SEF, SEF_L, SEF_R (EEG) SEF, SEF_L, SEF_R (indices reflecting the depth of sedation based on EEG analysis), TP (indices reflecting the magnitude of EEG based on EEG analysis), ARTIFACT and SQI (indices indicating the reliability of the obtained EEG indices), BIS (sedation indices obtained from EEG analysis), doses and concentrations of intravenous anesthetics used (propofol, fentanyl, PSI (sedation index obtained from EEG analysis), EEG data over time and power spectrum data.
These indicators will be analyzed cross-sectionally.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
During anesthesia, the older SedLine version is used
Interventions/Control_2
During anesthesia, the newer SedLine version is used
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to undergo elective surgery which require general anesthesia and tracheal intubation and provided written informed consent whose physical status in American Society of Anesthesiologists classification I or II.
Key exclusion criteria
Exclusion criteria includes known allergy to propofol; psychoneurotic disorders; psychiatric pharmacotherapy; chronic use of opioids; cirrhosis; and those who were considered inadequate.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Murakawa |
| Middle name | |
| Last name | Masahiro |
Organization
Fukushima Medical University
Division name
Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka Fukushima City, Fukushima
TEL
0245471342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinju |
| Middle name | |
| Last name | Obara |
Organization
Fukushima Medical University
Division name
Surgical Operation Department
Zip code
9601295
Address
1 Hikarigaoka Fukushima City, Fukushima
TEL
0245471342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University Research Ethics Committee
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
Tel
0245471825
rs@fmu.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
| 2017 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.minervamedica.it/en/journals/minerva-anestesiologica/article.php?cod=R02Y2021N07A0774
Publication of results
Partially published
Result
URL related to results and publications
https://www.minervamedica.it/en/journals/minerva-anestesiologica/article.php?cod=R02Y2021N07A0774
Number of participants that the trial has enrolled
36
Results
Compared to the old algorithm group, the incidence of abnormally high PSi values (AHPSi ) was significantly lower in the updated algorithm group (26.7% vs. 4.2%, P<0.001). Lower TP values and the use of the old algorithm have significant effect on increased PSi values (P<0.001).
Results date posted
| 2021 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 03 | Day |
Baseline Characteristics
36 elderly patients (60-85 years of age) with American Society of Anesthesiologists (ASA ) physical status of I or II who were scheduled for elective surgery
Participant flow
Using a computer-generated table of random numbers, patients were randomly allocated to two groups: a group to be assessed with the older version of the SedLine sensor and a group to be evaluated with the updated SedLine sensor.
Adverse events
None
Outcome measures
abnormally high PSi values (AHPSi).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031656
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