Clinical trial NCT06002568: Effect of Binaural Beats for Maintenance of General Anesthesia
Official title: ) The Effect of Intraoperative Binaural Beats on the Quantity of Inhaled Anesthetic Gas Required for the Maintenance of General Anesthesia: a Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia, General
Keywords: Sevoflurane
Brain waves
Binaural Beats
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized, placebo-controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for thyroidectomy without neuromonitoring
* Patients aged 20-60 who require general anesthesia over 2 hours
* Patients who are able to provide written consent to participate in the clinical trial, to understand the procedure of this clinical trial, and to fill out the questionnaire appropriately
* Patients with ASA physical status classification 1-2

Exclusion Criteria:

* Patients with hearing loss or using hearing aids
* Patients who received narcotic analgesics or sedative drugs within 1 week
* Patients with alcohol or drug dependence
* Patients with drug hypersensitivity to sevoflurane
* Patients with family history or past history of malignant hyperthermia
* Patients with neuromuscular disease of myasthenia gravis
* Patients with arrhythmia, cardiovascular disease, and decreased heart function
* Patients with kidney failure
* Patients who are judged to be inappropriate for this clinical trial according to the opinions of investigators

Primary outcomes:
measure: Average end tidal sevoflurane concentration
timeFrame: From the starting of surgery to the final suture of skin
Secondary outcomes:
measure: End tidal minimal alveolar concentration - Maximum
timeFrame: From the starting of surgery to the final suture of skin
measure: End tidal minimal alveolar concentration - Minimum
timeFrame: From the starting of surgery to the final suture of skin
measure: Anxiety
timeFrame: Right after arriving the operating room
measure: Anxiety
timeFrame: Just before leaving the post anesthesia care unit
measure: Vital sign
timeFrame: From the starting to the end of general anesthesia
measure: Vital sign
timeFrame: From the starting to the end of general anesthesia
measure: Vital sign
timeFrame: From the starting to the end of general anesthesia
measure: Brain wave
timeFrame: From the starting of surgery to the final suture of skin
measure: Brain wave
timeFrame: From the starting of surgery to the final suture of skin
measure: Post operative nausea vomiting
timeFrame: During the patients stay in post anesthesia care unit
measure: Post operative nausea vomiting
timeFrame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
measure: Post operative pain
timeFrame: While the patient stay in post anesthesia care unit
measure: Post operative pain
timeFrame: 24 hours after operation
measure: Delirium
timeFrame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
measure: Delirium
timeFrame: Since the patient leaves the post anesthesia care unit, until post operative 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hwa Seo, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
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