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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Music Group | Experimental | 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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| Control Group | No Intervention | Participants in this group will receive standard anesthesia care without intraoperative music. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Propofol Consumption | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bispectral Index Values | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selcan Akesen, MD | Contact | +90 224 295 32 74 | selcanakesen@uludag.edu.tr | |
| Gokce Kizilkale Kayikci, MD | Contact | +90 224 295 3124 | gkizilkale@uludag.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Uludag University Faculty of Medicine | Bursa | Bursa | 16059 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37646752 | Background | 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. | |
| 26277246 | Background | 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. |
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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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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Participants will be randomized into two parallel groups: intraoperative music plus standard anesthesia care or standard anesthesia care alone.
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The anesthesia team will not be blinded to group allocation. The surgeon, post-anesthesia care unit staff, and outcome assessor will not be informed of the assigned group.
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| 31356272 | Background | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |