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Intraoperative Music and Propofol Consumption in Breast Surgery

2026年8月25日 更新者：Selcan Akesen、Uludag University

The Effect of Intraoperative Music on Propofol Consumption and BIS Values in Patients Undergoing Elective Breast Surgery: A Randomized Controlled Trial

The goal of this study is to find out whether listening to music during surgery can reduce the amount of propofol, an anesthesia medicine, needed in patients having elective breast surgery.

Patients who agree to take part will be randomly assigned to one of two groups. One group will listen to music of their choice through headphones during anesthesia and recovery. The other group will receive standard anesthesia care without music. All patients will receive routine anesthesia monitoring, including a monitor that helps assess the depth of anesthesia.

The main outcome of the study is the total amount of propofol used during surgery. The study will also look at anesthesia depth values, use of other anesthesia medicine, blood pressure and heart rate, time spent in the recovery unit, nausea and vomiting after surgery, and patient satisfaction.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a single-center, prospective, randomized, controlled, two-arm study conducted at Bursa Uludag University Faculty of Medicine, Department of Anesthesiology and Reanimation. The study population will include adult patients scheduled for elective breast surgery under total intravenous anesthesia.

After providing written informed consent, eligible participants will be randomized into two groups. The control group will receive routine anesthesia care in a standard operating room environment. The music group will receive the same anesthesia protocol and will listen to self-selected music using noise-cancelling Bluetooth headphones from immediately before anesthesia induction until discharge from the post-anesthesia care unit.

All patients will undergo standard intraoperative monitoring, including electrocardiography, noninvasive blood pressure, pulse oximetry, capnography, and bispectral index monitoring. Anesthesia will be induced and maintained according to a standardized total intravenous anesthesia protocol using propofol and remifentanil. Propofol administration will be titrated to maintain the BIS value within the target range of 40-60.

The primary outcome is total propofol consumption expressed as mg/kg. Secondary outcomes include intraoperative BIS values recorded at regular intervals, remifentanil consumption, heart rate and blood pressure measurements, post-anesthesia care unit length of stay, postoperative nausea and vomiting, and patient satisfaction before discharge from the post-anesthesia care unit.

研究类型

介入性

注册 (估计的)

74

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age between 18 and 70 years
  • American Society of Anesthesiologists physical status I or II
  • Scheduled to undergo elective breast surgery with an estimated surgical duration of 45 to 180 minutes
  • Planned anesthesia technique is total intravenous anesthesia
  • Able to understand Turkish and communicate verbally
  • Able to read and write and provide written informed consent
  • Clinically normal hearing function and no ear, nose, or throat condition that prevents headphone use

Exclusion Criteria:

  • Diagnosed unilateral or bilateral hearing loss or use of a hearing aid
  • Current psychiatric disease or regular use of psychotropic medication, including antidepressants, antipsychotics, anxiolytics, or hypnotics
  • Diagnosis of chronic pain syndrome or chronic use of opioids, pregabalin, or gabapentin
  • Neurological disease that may affect BIS interpretation, such as epilepsy, dementia, stroke sequelae, or Parkinson disease
  • Known allergy or contraindication to propofol, remifentanil, or rocuronium
  • Morbid obesity, defined as body mass index greater than 40 kg/m²
  • History of active alcohol or substance dependence
  • Pregnancy or breastfeeding
  • Emergency surgery or reoperation
  • Planned addition of regional anesthesia in the preoperative period
  • Refusal to participate in the study or refusal to sign the informed consent form

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Intraoperative Music Group
Participants in this group will receive standard anesthesia care and will listen to self-selected music through noise-cancelling headphones from immediately before anesthesia induction until discharge from the post-anesthesia care unit.
行为的：Intraoperative Music
Participants assigned to the music group will listen to self-selected music through noise-cancelling Bluetooth headphones from immediately before anesthesia induction until discharge from the post-anesthesia care unit. Music volume will be set at approximately 50-60 dB. Standard anesthesia care will be provided according to the study protocol.
无干预：Control Group
Participants in this group will receive standard anesthesia care without intraoperative music.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Total Propofol Consumption
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
Total amount of propofol administered during anesthesia, normalized to body weight and expressed as mg/kg. Propofol consumption will be obtained from the target-controlled infusion pump records.
From anesthesia induction to the end of surgery, assessed up to 6 hours.

次要结果测量

结果测量
措施说明
大体时间
Bispectral Index Values
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
Bispectral index values will be recorded at 5-minute intervals during anesthesia to assess intraoperative depth of anesthesia.
From anesthesia induction to the end of surgery, assessed up to 6 hours.
Remifentanil Consumption
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
Remifentanil consumption during anesthesia will be calculated from target-controlled infusion pump records and expressed as mcg/kg/min
From anesthesia induction to the end of surgery, assessed up to 6 hours.
Mean Heart Rate
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
The mean intraoperative heart rate will be calculated using values recorded at 5-minute intervals during anesthesia and expressed as beats per minute.
From anesthesia induction to the end of surgery, assessed up to 6 hours.
Mean Systolic Arterial Pressure
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
The mean intraoperative systolic arterial pressure will be calculated using values recorded at 5-minute intervals during anesthesia and expressed as mmHg.
From anesthesia induction to the end of surgery, assessed up to 6 hours.
Mean Diastolic Arterial Pressure
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
The mean intraoperative diastolic arterial pressure will be calculated using values recorded at 5-minute intervals during anesthesia and expressed as mmHg.
From anesthesia induction to the end of surgery, assessed up to 6 hours.
Mean Arterial Pressure
大体时间：From anesthesia induction to the end of surgery, assessed up to 6 hours.
The mean arterial pressure during anesthesia will be calculated using values recorded at 5-minute intervals and expressed as mmHg.
From anesthesia induction to the end of surgery, assessed up to 6 hours.
Postoperative Nausea and Vomiting
大体时间：At 30 and 60 minutes after admission to the post-anesthesia care unit
The presence of postoperative nausea and vomiting will be assessed in the post-anesthesia care unit using a standard assessment form.
At 30 and 60 minutes after admission to the post-anesthesia care unit
Post-Anesthesia Care Unit Length of Stay
大体时间：From admission to the post-anesthesia care unit until discharge readiness from the post-anesthesia care unit, assessed up to 180 minutes.
Duration of stay in the post-anesthesia care unit will be recorded in minutes. Discharge from the post-anesthesia care unit will be based on an Aldrete score of 9 or higher
From admission to the post-anesthesia care unit until discharge readiness from the post-anesthesia care unit, assessed up to 180 minutes.
Patient Satisfaction
大体时间：Immediately before discharge from the post-anesthesia care unit, assessed up to 180 minutes after post-anesthesia care unit admission.
Patient satisfaction will be assessed using a 0-10 visual analog scale before discharge from the post-anesthesia care unit. Higher scores indicate greater satisfaction.
Immediately before discharge from the post-anesthesia care unit, assessed up to 180 minutes after post-anesthesia care unit admission.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Uludag University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月3日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MUSIC-BREAST-RCT-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because the study data contain clinical perioperative information and will be handled in accordance with institutional data protection requirements and Turkish personal data protection regulations. De-identified aggregate results may be reported in scientific publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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