[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intraoperative-responsiveness-during-general-anesthesia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intraoperative-responsiveness-during-general-anesthesia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100656824","evaluation-of-intraoperative-awareness-and-its-correlation-with-processed-eeg-biomarkers-during-laparoscopic-surgery-100656824",false,"NCT07831590","Evaluation of Intraoperative Awareness and Its Correlation With Processed EEG Biomarkers During Laparoscopic Surgery","Evaluation of Intraoperative Awareness During Laparoscopic Abdominal Surgery and Its Correlation With Processed Electroencephalography Biomarkers","Inclusion Criteria:\n\n* Age ≥18 years\n* Elective laparoscopic abdominal surgery planned\n* General anesthesia planned\n* Ability to communicate adequately\n* Adequate cognitive capacity to understand and respond to study procedures\n* ASA physical status I-III\n\nExclusion Criteria:\n\n* Previous cerebrovascular disease\n* Psychiatric disorders\n* Cognitive dysfunction\n* ASA physical status \\>III\n* High frailty\n* Body mass index \\>30 kg\u002Fm²\n* Pregnancy\n* Age \\\u003C18 years","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study aims to evaluate intraoperative responsiveness and possible intraoperative awareness in adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia and to investigate their relationship with processed electroencephalography (EEG) biomarkers.\n\nApproximately 600 patients will be enrolled. Preoperative assessment will include the 15-item Quality of Recovery questionnaire (QoR-15), State-Trait Anxiety Inventory (STAI), Mini-Mental State Examination (MMSE), and Beck Anxiety Inventory (BAI).\n\nProcessed EEG monitoring will be performed using the Masimo SedLine system. The system will be applied before induction of general anesthesia and maintained throughout the anesthetic period until extubation. Patient State Index (PSI) values will be recorded at 5-minute intervals from the beginning of surgery until extubation.\n\nThe isolated forearm technique (IFT) will be performed five times during predefined stages of anesthesia and surgery. The fifth assessment will be performed at any stage of surgery when there is clinical or processed EEG evidence suggesting possible awakening, including a PSI value above 50 and\u002For accompanying hemodynamic changes such as tachycardia or hypertension.\n\nPostoperative assessment will be performed at the 24th postoperative hour and at the second postoperative week. At 24 hours, QoR-15 and structured awareness questioning will be performed. At two weeks, QoR-15, Beck Anxiety Inventory, dream recall, and further assessment of possible intraoperative awareness will be performed.\n\nThe study will investigate the relationship between PSI changes, isolated forearm technique responses, and postoperative reports suggestive of intraoperative awareness.",[24,25],"Intraoperative Awareness","Intraoperative Responsiveness During General Anesthesia",[27,28,29,30,31],"Intraoperative awareness","Awareness during general anesthesia","Intraoperative responsiveness","Patient State Index; Processed EEG; SedLine","Isolated forearm technique","RECRUITING","2026-09-15",{"date":35,"type":36},"2026-09-21","ACTUAL",{"date":38,"type":36},"2026-02-01",{"date":40,"type":20},"2027-05-01",{"name":42,"class":43},"Duzce University","OTHER"]