Intraoperative Music and Propofol Consumption in Breast Surgery
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Selcan Akesen, MD
- Número de teléfono: +90 224 295 32 74
- Correo electrónico: selcanakesen@uludag.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Gokce Kizilkale Kayikci, MD
- Número de teléfono: +90 224 295 3124
- Correo electrónico: gkizilkale@uludag.edu.tr
Ubicaciones de estudio
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Bursa
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Bursa, Bursa, Turquía (Türkiye), 16059
- Reclutamiento
- Bursa Uludağ University Faculty of Medicine
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Contacto:
- Selcan Akesen, MD
- Número de teléfono: +90 224 295 32 74
- Correo electrónico: selcanakesen@uludag.edu.tr
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Contacto:
- Gokce Kizilkale Kayikci, MD
- Número de teléfono: +90 224 295 3124
- Correo electrónico: gkizilkale@uludag.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
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Sin intervención: Control Group
Participants in this group will receive standard anesthesia care without intraoperative music.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Propofol Consumption
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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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.
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bispectral Index Values
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Bispectral index values will be recorded at 5-minute intervals during anesthesia to assess intraoperative depth of anesthesia.
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Remifentanil Consumption
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Remifentanil consumption during anesthesia will be calculated from target-controlled infusion pump records and expressed as mcg/kg/min
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Mean Heart Rate
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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The mean intraoperative heart rate will be calculated using values recorded at 5-minute intervals during anesthesia and expressed as beats per minute.
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Mean Systolic Arterial Pressure
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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The mean intraoperative systolic arterial pressure will be calculated using values recorded at 5-minute intervals during anesthesia and expressed as mmHg.
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Mean Diastolic Arterial Pressure
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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The mean intraoperative diastolic arterial pressure will be calculated using values recorded at 5-minute intervals during anesthesia and expressed as mmHg.
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Mean Arterial Pressure
Periodo de tiempo: From anesthesia induction to the end of surgery, assessed up to 6 hours.
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The mean arterial pressure during anesthesia will be calculated using values recorded at 5-minute intervals and expressed as mmHg.
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From anesthesia induction to the end of surgery, assessed up to 6 hours.
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Postoperative Nausea and Vomiting
Periodo de tiempo: At 30 and 60 minutes after admission to the post-anesthesia care unit
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The presence of postoperative nausea and vomiting will be assessed in the post-anesthesia care unit using a standard assessment form.
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At 30 and 60 minutes after admission to the post-anesthesia care unit
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Post-Anesthesia Care Unit Length of Stay
Periodo de tiempo: From admission to the post-anesthesia care unit until discharge readiness from the post-anesthesia care unit, assessed up to 180 minutes.
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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
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From admission to the post-anesthesia care unit until discharge readiness from the post-anesthesia care unit, assessed up to 180 minutes.
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Patient Satisfaction
Periodo de tiempo: Immediately before discharge from the post-anesthesia care unit, assessed up to 180 minutes after post-anesthesia care unit admission.
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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.
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Immediately before discharge from the post-anesthesia care unit, assessed up to 180 minutes after post-anesthesia care unit admission.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MUSIC-BREAST-RCT-01
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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