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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-06-01

Brief Summary

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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 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.

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Detailed Description

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Operating room (OR) noise is a common but underestimated environmental factor that may affect both patients and medical staff. In patients under general anesthesia, excessive noise may influence depth of anesthesia, physiological stability, and recovery outcomes.This prospective observational study will investigate the correlation between intraoperative noise levels and bispectral index (BIS) values, as well as hemodynamic parameters (systolic, diastolic, and mean arterial pressure, and heart rate). Seventy adult patients undergoing elective surgery under general anesthesia will be monitored. Noise levels will be measured every 10 minutes with a calibrated sound level meter (CEM DT-8850), while BIS and hemodynamic parameters will be recorded at 10-minute and 5-minute intervals, respectively. Additionally, the type of noise (device-related, human-related, alarms, media) and the surgical branch (classified into high, moderate, or low noise categories) will be documented. Data will be analyzed to determine whether environmental noise correlates with BIS fluctuations and hemodynamic stability. The study is observational only and involves no intervention beyond standard anesthesia practice. Results are expected to raise awareness of environmental influences on anesthesia management and provide recommendations for OR organization to enhance patient safety.

Conditions

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General Anesthesia Hemodynamics Noise Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 (Noisy Group)

Patients exposed to average OR noise level \>65 dB during general anesthesia.

Intraoperative Noise Monitoring

Intervention Type OTHER

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.

2 (Quiet Group)

Patients exposed to average OR noise level \<55 dB during general anesthesia.

Intraoperative Noise Monitoring

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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CEM DT-8850 Sound Level Meter Operating Room Noise Measurement

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes