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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18-70

ASA (American Society of Anesthesiologists) physical status score I-II

Scheduled for elective surgery

To be undergoing general anesthesia

Disqualifiers

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

Trial population

Adult patients aged 18-70 years undergoing elective surgery under general anesthesia at Başakşehir Çam and Sakura City Hospital will be included. Eligible participants must have ASA physical status I-II, be cognitively able to provide informed consent, and scheduled for surgeries lasting up to 2 hours. Both male and female patients will be enrolled without restriction. Only elective (non-emergency) procedures are considered. Surgeries from multiple specialties (orthopedics, neurosurgery, cardiovascular, general surgery, gynecology, urology, ophthalmology, otolaryngology, plastic surgery, dermatology) will be included, representing high, moderate, and low noise exposure categories.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraoperative Noise Monitoring

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: 1 (Noisy Group)1 intervention
Group B: 2 (Quiet Group)1 intervention

Trial outcomes

Primary outcomes

1

Correlation between intraoperative noise levels and BIS values

Relationship between mean intraoperative noise levels (LAeq, dB(A)) and mean Bispectral Index (BIS) values during the maintenance phase of general anesthesia.

Time frame
10-minute intervals intraoperative period

Secondary outcomes

1

Relationship between intraoperative noise levels and hemodynamic parameters

Association between average intraoperative noise level (LAeq, dB(A)) and hemodynamic variables (systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate). Hemodynamic parameters will be recorded at 5-minute intervals, while noise levels will be measured at 10-minute intervals.

Time frame
Intraoperative period
2

Effect of noise source type on BIS and hemodynamic stability

Evaluation of whether noise source categories (device-related, human-related, alarms, media) are associated with changes in BIS and hemodynamic parameters. Noise type will be recorded by independent observer every 10 minutes.

Time frame
Intraoperative period.
3

Comparison of BIS and hemodynamic outcomes across surgical branches

Surgical specialties will be classified into high, moderate, or low noise categories. BIS and hemodynamic data will be compared across these groups.

Time frame
Intraoperative period.

Other outcomes

Sponsors and contacts

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