Prospective evaluation of patient state index using different versions of Sedline

Prospective evaluation of patient state index using different versions of Sedline - Patient state index in different versions of SedLine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027628

Enrollment

Registered

2017-06-05

Start date

2017-06-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified diseases which require general anesthesia during surgery

Interventions

During anesthesia, the older SedLine version is used During anesthesia, the newer SedLine version is used

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Exclusion criteria includes known allergy to propofol; psychoneurotic disorders; psychiatric pharmacotherapy; chronic use of opioids; cirrhosis; and those who were considered inadequate.

Design outcomes

Primary

Measure	Time frame
To compare the duration in which PSI values > 50 between different versions of SedLine when anesthesia is titrated so that BIS values around 50	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactShinju Obara

Fukushima Medical University Surgical Operation Department

masui@fmu.ac.jp0245471342

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026