Impact of Operating Room Noise on BIS and Hemodynamics During General Anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study enrolling 70 adults with ASA I-II who undergo elective surgery under general anesthesia. Noise levels in the operating room will be measured every 10 minutes and categorized as noisy or quiet, while BIS values are recorded every 10 minutes and hemodynamic parameters every 5 minutes during the maintenance phase. The analysis will examine correlations between intraoperative noise exposure and BIS fluctuations as well as blood pressure and heart rate stability. Additional data on noise type and surgical category will be collected to explore potential sources of noise and their relation to physiological responses. No interventions beyond standard anesthesia practice will be performed.

Why it matters

Who can join: the full rules

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

Where it's running

• Başakşehir Çam and Sakura City Hospital
  Başakşehir, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Emine Ozcan, MD — Başakşehir Çam & Sakura City Hospital
• Study coordinator: Emine Ozcan, MD
• Email: dr.emine3419@gmail.com
• Phone: +905301592856

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.