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Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia

Recruitingn/aAges 18 Years - 70 YearsAllBaşakşehir Çam & Sakura City Hospital
NCT07194707 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (\<55 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. Primary outcome is the correlation

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18-70 * ASA (American Society of Anesthesiologists) physical status score I-II * Scheduled for elective surgery * To be undergoing general anesthesia * Having signed the informed consent form to participate in the study Exclusion Criteria: * Hearing impairment or ear pathology * History of neurological disease (epilepsy, stroke, dementia, etc.) * Use of psychiatric medications (anxiolytics, antidepressants, antipsychotics, etc.) * Indications for emergency surgery * Planned spinal or epidural anesthesia * Conditions unsuitable for BIS monitoring * Cognitive impairment preventing informed consent
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What it tests

  • Intraoperative Noise Monitoring
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Where

1 site
Başakşehir Çam and Sakura City Hospital
Başakşehir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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