Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Noise Monitoring.
- Who it may be relevant to
- Registry conditions: General Anesthesia, Hemodynamics, Noise Exposure. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Correlation between intraoperative noise levels and BIS values [Time frame: 10-minute intervals intraoperative period]
Secondary outcome measures (3)
- Relationship between intraoperative noise levels and hemodynamic parameters [Time frame: Intraoperative period]
- Effect of noise source type on BIS and hemodynamic stability [Time frame: Intraoperative period.]
- Comparison of BIS and hemodynamic outcomes across surgical branches [Time frame: Intraoperative period.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Li X, Li J, Xu Z, Shang Y, Shi H. Effects of Operating Room Noise on Patient Outcomes and Medical Staff: A Systematic Review. Noise Health. 2025 May-Jun 01;27(126):246-254. doi: 10.4103/nah.nah_175_24. Epub 2025 Jun 26. PMID 40574295
- You S, Xu F, Zhu X, Qin S, Zheng X, Tao C, Wu Y, Chen Y, Shu B, Huang H, Duan G. Effect of intraoperative noise on postoperative pain in surgery patients under general anesthesia: evidence from a prospective study and mouse model. Int J Surg. 2023 Dec 1;109(12):3872-3882. doi: 10.1097/JS9.0000000000000672. PMID 37598384
- Jeyaraman M, Jeyaraman N, Yadav S, Nallakumarasamy A, Iyengar KP, Jain V. Impact of Excessive Noise Generation in Orthopaedic Operating Theatres: A Comprehensive Review. Cureus. 2024 Feb 19;16(2):e54469. doi: 10.7759/cureus.54469. eCollection 2024 Feb. PMID 38510860
- Louis M, Grabill N, Strom P, Gibson B. Leading Through Noise: Operating Room Noise Challenges for Staff and Leadership Techniques to Ensure Optimal Operational Performance. Cureus. 2024 Sep 17;16(9):e69569. doi: 10.7759/cureus.69569. eCollection 2024 Sep. PMID 39421089
Identifiers
NCT: NCT07194707 · SOUNDM3419