The goal of this clinical trial is to learn about the effects of binaural beats on maintenance of general anesthesia in patients undergoing thyroidectomy without intraoperative neuromonitoring. The main question it aims to answer is: * 1\) Does applying binaural beats during surgery reduce the gas anesthetics (especially sevoflurane) requirement to maintaining adequate anesthetic depth during general anesthesia? * 2\) Does applying binaural beats during surgery affect intraoperative hemodynamic stability or post operative nausea and vomiting? Participants will wear headsets with a sound generator which contains music files (binaural beat file in the intervention group (BB) ; silent file in control group (C)) according to the randomization. Researchers will compare the BB and C group to see if intraoperative binaural beats reduce the requirements of sevoflurane for maintaining adequate anesthetic depth.
This study will look at thyroidectomy patients without neuromonitoring. Before entering the operating room, patients will be randomized according to the randomization table, with the test group receiving a sound generating device with a binaural sound file and the control group receiving a sound generating device with a silent file. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthesia will be attached. At the beginning of anesthesia induction, the headset will be placed on the patient and a sound generator will be connected to the headset to play the file. The induction of anesthesia will be done with administration of fentanyl and propofol in both groups, and after confirming that the patient is unresponsive to voice, rocuronium and sevoflurane will be administrated to the patient. During the operation, the inhaled anesthetic concentration will be adjusted to maintain a patient state index (PSI) between 25 and 50. Fentanyl can be titrated up to 100 mcg to account for the hemodynamic response to intraoperative pain, and neuromuscular blocking agents are titrated to maintain a train of four (TOF) count of 1-3. The headset is continuously applied to the patient during surgery, and blood pressure, pulse oximetry, PSI, end tidal sevoflurane and end tidal minimal alveolar concentration will be monitored during the operation. At the time of the final suture of the skin, the sound generator will be removed from the headset. Save the raw EEG data from the Sedline® sensor for further analytical evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
122
Apply wave file created in silence.
Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.
Seoul National University Hospital
Seoul, South Korea
Average end tidal sevoflurane concentration
Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure
Time frame: From the starting of surgery to the final suture of skin
End tidal minimal alveolar concentration - Maximum
Maximal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
Time frame: From the starting of surgery to the final suture of skin
End tidal minimal alveolar concentration - Minimum
Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
Time frame: From the starting of surgery to the final suture of skin
Anxiety
Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), after entering the operating room
Time frame: Right after arriving the operating room
Anxiety
Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), just before leaving the post anesthesia care unit
Time frame: Just before leaving the post anesthesia care unit
Vital sign
Noninvasive blood pressure (systolic \& diastolic \& mean, mmHg)
Time frame: From the starting to the end of general anesthesia
Vital sign
Heart rate (bpm)
Time frame: From the starting to the end of general anesthesia
Vital sign
Saturation by pulse oximeter (%)
Time frame: From the starting to the end of general anesthesia
Brain wave
Patient state index (PSI) by Sedline device
Time frame: From the starting of surgery to the final suture of skin
Brain wave
brainwaves (raw data) which are collected in the Sedline device - alpha, beta, theta, delta, gamma brain wave
Time frame: From the starting of surgery to the final suture of skin
Post operative nausea vomiting
The incidence of post operative nausea vomiting, in the post anesthesia care unit
Time frame: During the patients stay in post anesthesia care unit
Post operative nausea vomiting
The incidence of post operative nausea vomiting, in the ward within 24 hours
Time frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
Post operative pain
Pain is evaluate in Numerical rating scales score (0-10, 0 for no pain and 10 for for worst pain imaginable), in the post anesthesia care unit
Time frame: While the patient stay in post anesthesia care unit
Post operative pain
Pain is evaluate in Numerical rating scales score (0-10, 0 for no pain and 10 for for worst pain imaginable), 24 hours after operation
Time frame: 24 hours after operation
Delirium
The incidence of delirium in the ward within 24 hours after operation
Time frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
Delirium
The incidence of delirium in the ward within 48 hours after operation
Time frame: Since the patient leaves the post anesthesia care unit, until post operative 48 hours
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