UMIN-CTR Clinical Trial

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
Email	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
Email	masui@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031656