Brainwave Entrainment During Emergence

Study Overview
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Brief Summary
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The investigators will compare whether there is a significant difference in the time required for general anesthesia recovery according to application of the binaural sound after surgery.

Detailed Description
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After entering the operating room, electrocardiogram, pulse oxygen saturation, blood pressure meter, and sedline are attached to start monitoring vital signs and patient state index (PSI). propofol and the remifentanil continuous infusion device is connected as close as possible to the catheter insertion site. Anesthesia is induced with total intravenous anesthesia (4 ng/mL of Remifentanil, 4 mg/mL of propofol). Rocuronium is administered after checking the patient's unconsciousness. When appropriate neuromuscular blocking is reached, tracheal intubation is performed. The anesthesia maintenance is performed to keep stable vital sign and PSI between 25 and 50. End-tidal carbon dioxide is controlled to be between 30 mmHg and 40 mmHg. When the pneumoperitoneum ends, the propofol concentration is recorded (T0). The anesthesiologist in charge of anesthesia puts headphones on the patient and plays the allocated file. The allocated file is named the screening number. Depending on the allocated group, the audio file is binaural sound for the experimental group, and a silent file for the control group. The anesthesiologist cannot know group allocation, since the length and size of files are the same. Thereafter, the target of PSI is to be between 40 and 50. If the Psi increases above 50, increase the propofol concentration by 0.5 mg/mL and record it. Train of four counts keep between 1 to 3 (moderate block). When the operation is ended, stop anesthetics administration, and record the time (T1). At the same time, the investigators reverse neuromuscular blocking using sugammadex (2mg/ kg). When the anesthesiologist starts waking the patient up, call the patient's name (unify into OOO, open your eyes.). The anesthesiologist lightly tap the patient's shoulder and avoid excessive sound or stimulation. Record the time (T2) when the PSI reaches 50, the time when the patient opens eyes (T3), and the time (T4) when the extubation of endotracheal tube was done. T3-T1 is the time it took the patient to open his eyes (primary end point). Write the effect site concentration of propofol and remifentanil recorded for each time points. The patient's sedline EEG data from the end of pneumoperitoneum until the patient's exit operating room is collected as raw data. The patient's blood pressure and heart rate are measured at each time points. The investigators evaluate sedation and agitation of the patients using Ramsay Sedation Scale. In the post-anesthesia care unit, pain score (NRS 0-10), postoperative nausea vomiting, medication, and length of stay are investigated.

Official Title
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The Effect of Binaural Sound on Recovery of General Anesthesia in Patients Undergoing Laparoscopic Simple Gynecological Surgery

Conditions
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Anesthesia, General

Intervention / Treatment
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* Other: Binaural sound
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 19 and 50 years of age who are scheduled to undergo laparoscopic salpingo-oophorectomy/ ovarian cystectomy Intellectual level to understand the procedures of the clinical trial Physical status classification of the American Society of Anesthesiology (ASA) 1-2 grades Exclusion Criteria: Patients with hearing loss or using hearing aids Patients who have been given narcotic painkillers or sedative drugs within a week. Alcohol-dependent or drug-dependent patients Patients with drug hypersensitivity to anesthetics Patients with arrhythmia, cardiovascular disease, impaired heart function, decreased circulatory blood flow Patients with liver failure Patients with other major medical or psychological disorder that will affect the treatment response Patients with claustrophobia or anxiety disorder Patients with organic brain disorders or other conditions that cannot be properly measured by PSI Patients who have been newly diagnosed with myocardial infarction, cerebral ischemic seizure, stroke, clinically significant coronary artery disease, or have undergone percutaneous carotid coronary dilatation or coronary bypass treatment within 6 months Patients with a history of epilepsy or seizures Patients with acute angle glaucoma Patients who deemed unsuitable for this clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment A prospective randomized study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binaural<br>Exposed to binaural sound (40 Hz) from the end of pneumoperitoneum until the eyes are open | Other: Binaural sound<br>* When the pneumoperitoneum ends, the anesthesiologist puts headphones on the patient and plays the allocated file. In the experimental group, the allocated file is binaural sound with 40Hz beat. Thereafter, the target of PSI is to be between 40 and 50. If the Psi increases above 50, increase the propofol concentration by 0.5 mg/mL and record it. Train of four counts keep between 1 to 3 (moderate block). When the operation is ended, stop anesthetics administration, and, we reverse neuromuscular blocking using sugammadex (2mg/ kg). When the anesthesiologist starts waking the patient up, call the patient's name (unify into OOO, open your eyes.). The anesthesiologist lightly tap the patient's shoulder and avoid excessive sound or stimulation.<br>|
| Active Comparator: Control<br>Applied silent files from the end of pneumoperitoneum until the eyes are open | Other: Control<br>* When the pneumoperitoneum ends, the anesthesiologist puts headphones on the patient and plays the allocated file. In the control group, the allocated file is silent. Thereafter, the target of PSI is to be between 40 and 50. If the Psi increases above 50, increase the propofol concentration by 0.5 mg/mL and record it. Train of four counts keep between 1 to 3 (moderate block). When the operation is ended, stop anesthetics administration, and, we reverse neuromuscular blocking using sugammadex (2mg/ kg). When the anesthesiologist starts waking the patient up, call the patient's name (unify into OOO, open your eyes.). The anesthesiologist lightly tap the patient's shoulder and avoid excessive sound or stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye opening time | The time it takes to open patient's eyes in response to the voice after the anesthetic infusion is terminated. | after the anesthetic infusion is terminated until 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation time | The time it takes from the end of the anesthetic infusion to the extubation of endotracheal tube | after the anesthetic infusion is terminated until 1 hour | 
| Systolic blood pressure | Noninvasive systolic blood pressure | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| Diastolic blood pressure | Noninvasive diastolic blood pressure | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| Mean blood pressure | Noninvasive mean blood pressure | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| Heart rate | Heart rate | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| alpha band activity | alpha band activity of electroencephalogram from Sedline data | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| beta band activity | beta band activity of electroencephalogram from Sedline data | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| theta band activity | theta band activity of electroencephalogram from Sedline data | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| delta band activity | delta band activity of electroencephalogram from Sedline data | from the end of the anesthetic infusion to the exit of operating room until 1 hour | 
| Ramsay Sedation Scale | The degree of patient's sedation or agitation (1 to 6: 1 means Patient is anxious and agitated or restless, or both; 6 means Patient exhibits no response) | When the end of anesthesia within 5minutes | 
| Postoperative recovery score | Postoperative recovery score (0-10; activity (0-2), respiration (0-2), circulation (0-2), consciousness level (0-2), and color (0-2); optimum score 10) | When the patient stay in post-anesthesia care unit up to 1 hour | 
| Pain score | Postoperative pain score using numeric rating scale(0-10: 0, no pain; 10, worst possible pain) | When the patient stay in post-anesthesia care unit up to 1 hour | 
| Rate of postoperative nausea and vomiting | Rate of postoperative nausea and vomiting | When the patient stay in post-anesthesia care unit up to 1 hour | 
| Length of stay in post-anesthesia care unit | Length of stay in post-anesthesia care unit | From entering to exit the post-anesthesia care unit up to 2 hours | 
| Medication | Rate of administration of any medication in post-anesthesia care unit | When the patient stay in post-anesthesia care unit up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Waves, anesthesia