Intraoperative Music and Propofol Consumption in Breast Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUludag University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intraoperative Music
BehavioralParticipants 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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Intraoperative Music GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From anesthesia induction to the end of surgery, assessed up to 6 hours.Secondary outcomes
1
Bispectral Index Values
Bispectral index values will be recorded at 5-minute intervals during anesthesia to assess intraoperative depth of anesthesia.
Time frame
From anesthesia induction to the end of surgery, assessed up to 6 hours.2
Remifentanil Consumption
Remifentanil consumption during anesthesia will be calculated from target-controlled infusion pump records and expressed as mcg/kg/min
Time frame
From anesthesia induction to the end of surgery, assessed up to 6 hours.3
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.
Time frame
From anesthesia induction to the end of surgery, assessed up to 6 hours.4
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.
Time frame
From anesthesia induction to the end of surgery, assessed up to 6 hours.Sponsors and contacts
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Source ClinicalTrials.gov