Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063089) titled 'Agreement Between SedLine-Derived BIS Calculated From SedLine EEG and Native BIS Monitor Values in Patients Undergoing General Anesthesia: A Prospective Observational Study' on Sept. 29.

Study Type: Observational

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Adult patients undergoing general anesthesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective is to evaluate agreement between SedLine-derived BIS calculated from SedLine raw EEG and native BIS obtained from a simultaneously applied BIS monitor in patients undergoing general anesthesia, using repeated-measures Bland-Altman analysis. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 18 years or older at the time informed consent was obtained. 2. American Society of Anesthesiologists Physical Status (ASA-PS) class I or II. 3. Scheduled to undergo surgery under general anesthesia at Fukushima Medical University Hospital. 4. pEEG monitoring with SedLine is planned intraoperatively, or the attending anesthesiologist determines that placement of SedLine is clinically acceptable. 5. Surgery is performed in the supine or lithotomy position. 6. Scheduled surgery is an orthopedic or gynecologic procedure. 7. Written informed consent for study participation is obtained from the participant. Key exclusion criteria - 1. Central nervous system disease, including cognitive impairment, stroke, epilepsy, brain tumor, or psychiatric disease. 2. Use of medications with substantial effects on the central nervous system, including antiepileptic drugs, benzodiazepines, or hypnotics. 3. Known or suspected risk of contact dermatitis or allergic symptoms from application of the study devices. 4. High risk associated with anesthetic management. 5. Data cannot be collected because of limited device availability. Target Size - 65

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 19 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072199

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