Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059787) titled 'Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study' on Nov. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Patients undergoing general anesthesia in the operation room Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study was to determine whether the aperiodic component of the anesthesia EEG can assess the depth of anesthesia during remimazolam-based general anesthesia. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Administration of remimazolam

Eligibility: Age-lower limit - 40 years-old

Gender - Female Key inclusion criteria - 1. Patients managed by the attending anesthesiologist

2. Female sex

3. Age between 40 and 65 years

4. ASA physical status I or II Key exclusion criteria - 1. Inability to obtain informed consent

2. Presence of central nervous system disorders (cognitive impairment, stroke, epilepsy, brain tumor, or psychiatric disorders)

3. Use of antiepileptic drugs

4. Allergy to benzodiazepines

5. Current use of benzodiazepines

6. Risk of difficult airway, defined as: Obesity with a BMI greater than 30 Upper lip bite test class 3 Difficult airway anticipated by the attending anesthesiologist

7. Any other condition judged inappropriate for the study by the attending anesthesiologist or the principal investigator Target Size - 23

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 14 Day Date of IRB - 2025 Year 11 Month 14 Day Anticipated trial start date - 2025 Year 11 Month 15 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068361

Disclaimer: Curated by HT Syndication.