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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

74

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
介入なし：Control Group
Participants in this group will receive standard anesthesia care without intraoperative music.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Total Propofol Consumption
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Bispectral Index Values
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Uludag University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月3日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年6月24日

QC基準を満たした最初の提出物

2026年6月29日

最初の投稿 (実際)

2026年7月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月26日

QC基準を満たした最後の更新が送信されました

2026年8月25日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MUSIC-BREAST-RCT-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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