[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656824":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":52,"studyPopulation":53,"armGroups":54,"interventions":48,"overallOfficials":48,"centralContacts":73,"locations":79,"responsibleParty":94,"collaborators":48,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":48,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":48,"enrollmentInfo":105,"targetDuration":48,"studyType":108,"phases":48,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":81,"whyStopped":48,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Duzce University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Association Between Positive Isolated Forearm Technique Responses and Patient State Index Changes","The primary outcome is the association between positive responses obtained using the isolated forearm technique and changes in Patient State Index (PSI) values during general anesthesia. PSI values will be recorded at 5-minute intervals from the beginning of surgery until extubation. PSI changes occurring during or immediately surrounding positive IFT responses will be evaluated.","From the beginning of surgery until extubation",[14,18,22,26,30,34,38,41,45],{"measure":15,"description":16,"timeFrame":17},". Intraoperative Responsiveness","Frequency of positive isolated forearm technique responses during general anesthesia.","During induction and surgery.",{"measure":19,"description":20,"timeFrame":21},". PSI Increase Associated With IFT Positivity","Magnitude of PSI increase associated with positive isolated forearm technique responses compared with preceding PSI measurements","During surgery",{"measure":23,"description":24,"timeFrame":25},"Postoperative Awareness at 24 Hours","Patient-reported recall or experiences suggestive of intraoperative awareness assessed by structured postoperative questioning.","24 hours after surgery.",{"measure":27,"description":28,"timeFrame":29},"Postoperative Awareness at 2 Weeks","Patient-reported recall or experiences suggestive of intraoperative awareness assessed at the second postoperative week.","2 weeks after surgery",{"measure":31,"description":32,"timeFrame":33},"Quality of Recovery","Change in QoR-15 score from the preoperative assessment to 24 hours and 2 weeks after surgery.","Preoperatively, 24 hours postoperatively, and 2 weeks postoperatively.",{"measure":35,"description":36,"timeFrame":37},"Postoperative Anxiety","Change in Beck Anxiety Inventory score from the preoperative assessment to the second postoperative week and its association with possible intraoperative awareness.","Preoperatively and 2 weeks postoperatively.",{"measure":39,"description":40,"timeFrame":29},"Dream Recall","Presence of dream recall and its association with possible intraoperative awareness.",{"measure":42,"description":43,"timeFrame":44},"Preoperative Anxiety","Preoperative state and trait anxiety levels assessed using the State-Trait Anxiety Inventory","Preoperatively",{"measure":46,"description":47,"timeFrame":44},"Cognitive Status",": Preoperative cognitive status assessed using the Mini-Mental State Examination",null,{"allocation":48,"interventionModel":48,"interventionModelDescription":48,"primaryPurpose":48,"observationalModel":50,"timePerspective":51,"maskingInfo":48},"COHORT","PROSPECTIVE",": Intraoperative awareness is a clinically important complication of general anesthesia in which patients may experience consciousness and subsequently recall events occurring during anesthesia. Intraoperative responsiveness and postoperative explicit recall represent related but distinct aspects of consciousness during general anesthesia.\n\nThis prospective observational cohort study will include adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Approximately 600 participants will be prospectively enrolled.\n\nBefore surgery, participants will undergo baseline assessment using the QoR-15, State-Trait Anxiety Inventory, Mini-Mental State Examination, and Beck Anxiety Inventory.\n\nProcessed EEG monitoring will be performed using the Masimo SedLine system. The SedLine system will be applied before induction of general anesthesia and maintained throughout the anesthetic period until extubation. PSI values will be recorded at 5-minute intervals from the beginning of surgery until extubation.\n\nThe isolated forearm technique will be used to assess intraoperative responsiveness. The first four IFT assessments will be performed at predefined stages during induction and surgery. A fifth IFT assessment will be performed when the clinical course or monitoring suggests possible awakening, including a PSI value above 50 and\u002For hemodynamic findings such as tachycardia or hypertension. During the IFT, patients will be instructed to respond to a predefined verbal command, and the presence or absence of a response will be recorded.\n\nPSI values corresponding to IFT assessments will be evaluated. Particular attention will be given to increases in PSI associated with positive IFT responses. A positive IFT response together with an increase in PSI will be considered evidence of intraoperative responsiveness and possible intraoperative awareness rather than definitive proof of explicit postoperative awareness.\n\nAt the 24th postoperative hour, patients will undergo QoR-15 assessment and structured questioning regarding possible intraoperative awareness and recall. At the second postoperative week, QoR-15 and Beck Anxiety Inventory assessments will be repeated, and dream recall and possible intraoperative awareness will be assessed.\n\nThe study will investigate the relationship between processed EEG-derived PSI values, intraoperative responsiveness detected by the isolated forearm technique, and postoperative reports suggestive of awareness. It will also evaluate associations between possible intraoperative awareness and postoperative quality of recovery, anxiety, and dream recall.","The study population will consist of adult patients aged 18 years or older who are scheduled for elective laparoscopic abdominal surgery under general anesthesia. Patients who meet the predefined inclusion criteria and do not meet any exclusion criteria will be prospectively enrolled. The planned sample size is approximately 600 participants.",[55,58,61,64,67,70],{"label":56,"type":48,"description":57,"interventionNames":48},"type 0","Unconscious No signal; No response to commands No recall No recall Adequate anesthesia",{"label":59,"type":48,"description":60,"interventionNames":48},"type1","Intraoperative awareness Signal present Responds to commands No recall No recall or emotional consequences Wakefulness during surgery, erased explicit and implicit memory",{"label":62,"type":48,"description":63,"interventionNames":48},"type2","Intraoperative awareness (Cue words provided) Signal present Responds to commands No explicit recall, Implicit memory for provided words No explicit recall; Implicit memory for provided words but no emotional consequences Wakefulness during surgery and subsequent implicit memory",{"label":65,"type":48,"description":66,"interventionNames":48},"type3","Intraoperative awareness Signal present Responds to commands No recall PTSD\u002Fnightmares present but no explicit memory Wakefulness during surgery and implicit emotional memory",{"label":68,"type":48,"description":69,"interventionNames":48},"type4","Intraoperative awareness Signal present Responds to commands Explicit recall with or without pain Explicit memory present but no emotional consequences Awareness present but resilient patient (no emotional damage)",{"label":71,"type":48,"description":72,"interventionNames":48},"type5","Intraoperative awareness Signal present Responds to commands Explicit recall accompanied by distress and\u002For pain Explicit memory with PTSD\u002Fnightmares Awareness with emotional damage",[74],{"name":75,"role":76,"phone":77,"phoneExt":48,"email":78},"tuğçe altıkardeşler","CONTACT","05535891881","tucetin4705@hotmail.com",[80],{"facility":5,"status":81,"city":82,"state":48,"zip":48,"country":83,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Düzce","Turkey (Türkiye)",{"type":85,"coordinates":86},"Point",[87,88],31.16389,40.83889,{"lat":88,"lon":87},[91],{"name":92,"role":76,"phone":93,"phoneExt":48,"email":78},"duzce university","08502598181",{"type":95,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","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":106,"type":107},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.",[111,112],"Intraoperative Awareness","Intraoperative Responsiveness During General Anesthesia",[114,115,116,117,118],"Intraoperative awareness","Awareness during general anesthesia","Intraoperative responsiveness","Patient State Index; Processed EEG; SedLine","Isolated forearm technique","2026-09-15",{"date":121,"type":122},"2026-09-21","ACTUAL",{"date":124,"type":122},"2026-02-01",{"date":126,"type":107},"2027-05-01",{"name":5,"class":6},1]