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

NCT07194707 | Not Yet Recruiting

• 1 other identifier: SOUNDM3419
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

General Anesthesia; Hemodynamics; Noise Exposure

Keywords

Anesthesia, General; Operating Rooms; Monitoring, Intraoperative; Hemodynamics; Bispectral Index (BIS); Noise Exposure

Outcome Measures

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.

  10-minute intervals intraoperative period

Secondary Outcomes (3)

• Relationship between intraoperative noise levels and hemodynamic parameters

  Intraoperative period

• Effect of noise source type on BIS and hemodynamic stability

  Intraoperative period.

• Comparison of BIS and hemodynamic outcomes across surgical branches

  Intraoperative period.

Study Arms (2)

1 (Noisy Group)

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

Other: Intraoperative Noise Monitoring

2 (Quiet Group)

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

Other: Intraoperative Noise Monitoring

Interventions

Intraoperative Noise Monitoring 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.

Also known as: CEM DT-8850 Sound Level Meter, Operating Room Noise Measurement

1 (Noisy Group); 2 (Quiet Group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Emine Ozcan, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Ozcan, MD

CONTACT

+905301592856; dr.emine3419@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share