NCT Number: NCT07194707
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: CEM DT-8850 Sound Level Meter, Operating Room Noise Measurement
Time frame: 10-minute intervals intraoperative period
Relationship between mean intraoperative noise levels (LAeq, dB(A)) and mean Bispectral Index (BIS) values during the maintenance phase of general anesthesia.
Time frame: Intraoperative period
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.
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.
Surgical specialties will be classified into high, moderate, or low noise categories. BIS and hemodynamic data will be compared across these groups.
Contact information is provided by the study sponsor or research team.
Başakşehir Çam & Sakura City Hospital
Other Gov
The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study
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