General AnesthesiaNCT07194707
Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia
An observational study of General Anesthesia and Hemodynamics, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia, Hemodynamics, Noise Exposure
- What is being tested?
- Intraoperative Noise Monitoring
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 30 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Başakşehir, Istanbul, 34480
Emine ÖZCAN, MD, 05301592856, dr.emine3419@gmail.com
About this study
Official title: The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study
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.
Read the 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.
- Conditions
- General Anesthesia, Hemodynamics, Noise Exposure
- Being tested
- Intraoperative Noise Monitoring
- Keywords
- Anesthesia, General, Operating Rooms, Monitoring, Intraoperative, Hemodynamics, Bispectral Index (BIS), Noise Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Noise MonitoringOther
Also called CEM DT-8850 Sound Level Meter, Operating Room Noise Measurement
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 (Noisy Group) | Patients exposed to average OR noise level >65 dB during general anesthesia. Receives: Other: Intraoperative Noise Monitoring | |
| 2 (Quiet Group) | Patients exposed to average OR noise level <55 dB during general anesthesia. Receives: Other: Intraoperative Noise Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-minute intervals intraoperative period
Secondary outcomes (3)
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.
Measured: Intraoperative period
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.
Measured: Intraoperative period.
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.
Measured: Intraoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Sep 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine OZCAN, Başakşehir Çam & Sakura City Hospital
- Investigators
- Emine Ozcan, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194707
- Sponsor's protocol ID
- SOUNDM3419
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. Only aggregated results will be published in scientific journals and conferences.
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.
PubMed 40574295You 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.
PubMed 37598384Jeyaraman 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.
PubMed 38510860Louis 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.
PubMed 39421089
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07194707
- Acronym / sponsor ID
- SOUNDM3419
- Conditions
- General Anesthesia, Hemodynamics, Noise Exposure
- Keywords
- Anesthesia, General, Operating Rooms, Monitoring, Intraoperative, Hemodynamics, Bispectral Index (BIS), Noise Exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Noisy Group) | – | Other: Intraoperative Noise MonitoringPatients exposed to average OR noise level >65 dB during general anesthesia. |
| 2 (Quiet Group) | – | Other: Intraoperative Noise MonitoringPatients exposed to average OR noise level <55 dB during general anesthesia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Noise MonitoringAlso: CEM DT-8850 Sound Level Meter, Operating Room Noise MeasurementNoise 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 | 1 (Noisy Group), 2 (Quiet Group) |
Primary outcome
Correlation between intraoperative noise levels and BIS values
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 40574295Li 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.
- Background: PubMed 37598384You 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.
- Background: PubMed 38510860Jeyaraman 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.
- Background: PubMed 39421089Louis 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. Only aggregated results will be published in scientific journals and conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine Ozcan, MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Hemodynamics, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Ozcan, MD (+905301592856, dr.emine3419@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between intraoperative noise levels and BIS values (time frame: 10-minute intervals intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194707, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.