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临床试验/NCT07194707
NCT07194707尚未招募不适用

The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study

Başakşehir Çam & Sakura City Hospital0 个研究点目标入组 70 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
Correlation between intraoperative noise levels and BIS values

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

1 (Noisy Group)

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

干预措施: Intraoperative Noise Monitoring (Other)

2 (Quiet Group)

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

干预措施: Intraoperative Noise Monitoring (Other)

结局指标

主要结局

Correlation between intraoperative noise levels and BIS values

时间窗: 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.

次要结局

  • Relationship between intraoperative noise levels and hemodynamic parameters(Intraoperative period)
  • Comparison of BIS and hemodynamic outcomes across surgical branches(Intraoperative period.)
  • Effect of noise source type on BIS and hemodynamic stability(Intraoperative period.)

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Emine OZCAN

Principal Investigator

Başakşehir Çam & Sakura City Hospital

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