[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607911":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":10,"responsibleParty":36,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":53,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1 (Noisy Group)",null,"Patients exposed to average OR noise level \\>65 dB during general anesthesia.",[13],"Other: Intraoperative Noise Monitoring",{"label":15,"type":10,"description":16,"interventionNames":17},"2 (Quiet Group)","Patients exposed to average OR noise level \\\u003C55 dB during general anesthesia.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","Intraoperative Noise Monitoring","Noise levels will be passively measured during surgery using a calibrated sound level meter (CEM DT-8850) placed near the patient's head. Measurements will be taken every 10 minutes without physical contact or interference with clinical care. The procedure is purely observational and does not modify anesthesia or surgical practice.",[9,15],[25,26],"CEM DT-8850 Sound Level Meter","Operating Room Noise Measurement",[28],{"name":29,"affiliation":5,"role":30},"Emine Ozcan, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+905301592856","dr.emine3419@gmail.com",{"type":30,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Emine OZCAN","Principal Investigator","100607911","effect-of-operating-room-noise-on-bis-and-hemodynamics-under-general-anesthesia-100607911",false,"NCT07194707","Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia","The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study","Inclusion Criteria:\n\n* Adults aged 18-70\n* ASA (American Society of Anesthesiologists) physical status score I-II\n* Scheduled for elective surgery\n* To be undergoing general anesthesia\n* Having signed the informed consent form to participate in the study\n\nExclusion Criteria:\n\n* Hearing impairment or ear pathology\n* History of neurological disease (epilepsy, stroke, dementia, etc.)\n* Use of psychiatric medications (anxiolytics, antidepressants, antipsychotics, etc.)\n* Indications for emergency surgery\n* Planned spinal or epidural anesthesia\n* Conditions unsuitable for BIS monitoring\n* Cognitive impairment preventing informed consent",true,"ALL","18 Years","70 Years",{"count":51,"type":52},70,"ESTIMATED","1 Day","OBSERVATIONAL","This prospective observational study aims to evaluate the impact of operating room noise on bispectral index (BIS) and hemodynamic parameters in patients undergoing general anesthesia. Environmental noise in operating rooms, often overlooked, may influence anesthesia depth, patient safety, and physiological stability. A total of 70 adult patients (ASA I-II, 18-65 years, elective surgery under general anesthesia) will be enrolled at Başakşehir Çam and Sakura City Hospital. Patients will be categorized into two groups based on intraoperative average noise levels: noisy group (\\>65 dB) and quiet group (\\\u003C55 dB). Noise levels will be measured every 10 minutes using a CEM DT-8850 sound level meter, BIS will be recorded every 10 minutes, and hemodynamic variables (systolic, diastolic, mean arterial pressure, and heart rate) will be recorded every 5 minutes.\n\nPrimary outcome is the correlation between mean intraoperative noise levels (LAeq) and BIS values during the maintenance phase of anesthesia. Secondary outcomes include the relationship between noise characteristics (e.g., device-related, human-related, alarms, media) and hemodynamic stability, as well as surgical branch-related noise classifications (high, moderate, low). The study is non-interventional, with no additional risk to participants beyond standard clinical monitoring. Findings are expected to provide evidence on the role of environmental noise in anesthesia quality, inform operating room organization, and contribute to patient safety improvements.",[57,58,59],"General Anesthesia","Hemodynamics","Noise Exposure",[61,62,63,58,64,59],"Anesthesia, General","Operating Rooms","Monitoring, Intraoperative","Bispectral Index (BIS)","NOT_YET_RECRUITING","2026-01-03",{"date":68,"type":69},"2026-01-06","ACTUAL",{"date":71,"type":52},"2026-02-01",{"date":73,"type":52},"2026-06-01",{"name":5,"class":6}]