Intraoperative Music and Propofol Consumption in Breast Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Total Propofol Consumption [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]

Вторичные конечные точки (9)

• Bispectral Index Values [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]
• Remifentanil Consumption [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]
• Mean Heart Rate [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]
• Mean Systolic Arterial Pressure [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]
• Mean Diastolic Arterial Pressure [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]
• Mean Arterial Pressure [Срок оценки: From anesthesia induction to the end of surgery, assessed up to 6 hours.]
• Postoperative Nausea and Vomiting [Срок оценки: At 30 and 60 minutes after admission to the post-anesthesia care unit]
• Post-Anesthesia Care Unit Length of Stay [Срок оценки: From admission to the post-anesthesia care unit until discharge readiness from the post-anesthesia care unit, assessed up to 180 minutes.]
• Patient Satisfaction [Срок оценки: Immediately before discharge from the post-anesthesia care unit, assessed up to 180 minutes after post-anesthesia care unit admission.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Bursa Uludag University Faculty of Medicine — Bursa

Публикации

• Li G, Yu L, Yang Y, Deng J, Shao L, Zeng C. Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2024 Jan;30(1):37-46. doi: 10.1089/jicm.2022.0803. Epub 2023 Aug 30. PMID 37646752
• Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12. PMID 26277246
• Fu VX, Oomens P, Klimek M, Verhofstad MHJ, Jeekel J. The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis. Ann Surg. 2020 Dec;272(6):961-972. doi: 10.1097/SLA.0000000000003506. PMID 31356272

Идентификаторы

NCT: NCT07687095 · MUSIC-BREAST-RCT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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