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NCT Number: NCT07687095

Intraoperative Music and Propofol Consumption in Breast Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Music

Behavioral

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.

Primary outcomes

  1. Total Propofol Consumption

    Time frame: 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.

Secondary outcomes

  1. Bispectral Index Values

    Time frame: 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.

  2. Remifentanil Consumption

    Time frame: 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

  3. Mean Heart Rate

    Time frame: 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.

  4. Mean Systolic Arterial Pressure

    Time frame: 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.

  5. Mean Diastolic Arterial Pressure

    Time frame: 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.

  6. Mean Arterial Pressure

    Time frame: 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.

  7. Postoperative Nausea and Vomiting

    Time frame: 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.

  8. Post-Anesthesia Care Unit Length of Stay

    Time frame: 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

  9. Patient Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gokce Kizilkale Kayikci, MD

CONTACT

[email protected]

+90 224 295 3124

Selcan Akesen, MD

CONTACT

[email protected]

+90 224 295 32 74

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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