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Intraoperative Music and Propofol Consumption in Breast Surgery

25. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

74

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Kein Eingriff: Control Group
Participants in this group will receive standard anesthesia care without intraoperative music.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Propofol Consumption
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bispectral Index Values
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Uludag University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. August 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2026

Zuerst gepostet (Tatsächlich)

7. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MUSIC-BREAST-RCT-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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