NCT05431881

Binaural Sound Effects for General Anesthesia

The Effect of Preoperative Binaural Sound on Propofol Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

30 minutes before entering the operating room, the anxiety score is evaluated using a visual analogue scale (VAS) score, and stereo headphones, which can transmit binaural beat, are put on. According to a computer-generated assignment table, subjects are divided into an experimental group and a control group. Binaural beat is applied to the experimental group for 20 minutes, and a silent state is applied to the control group for 20 minutes. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthsia are attached. Before induction of anesthesia, the anxiety score is evaluated on a VAS, again. For anesthesia induction, propofol is administered at a rate of 10 mg every 15 seconds over 5 seconds. Assess the amount of propofol administered until the response to voice ("Open your eyes.") is absent, the subject's eyelash reflex disappears, and the PSI reaches below 50. Discontinue propofol injection when all three assessments (unresponsiveness to voice, loss of eyelash reflexes, Patient Sate Index (PSI) ≤ 50) become positive.

Detailed description

30 minutes before entering the operating room, anxiety is evaluated on a VAS score (0-100mm, a ruler without scale) and stereo headphones, which can transmit binaural beat, are put on. A third party unrelated to the experiment sees the randomization table and applies binaural sound to the experimental group and silent state (silent sound file) to the control group for 20 minutes. The sound generator is a smartphone device, which is hung on the transport bed. The volume is set to a level corresponding to 60dB. After entering the operating room, start monitoring vital signs and depth of anesthesia (PSI) by attaching an electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sedline. Prepare by connecting a 3-way at the most proximal part of the intravenous cannula. After changing the volume to 0, take off the headphones, and evaluate the anxiety score using VAS. Preoxygenation with oxygen 8L/min is sufficient, and in order to reduce venous pain caused by propofol injection, 1% lidocaine 50mg is pre-administrated. For anesthesia induction, 10mg propofol is administered every 15 seconds for 5 seconds. Assess the amount and time of propofol administered until the response to the voice ("Open your eyes.") is absent, the patient's eyelash reflex disappears, and the PSI reaches below 50. Propofol is administered until all three evaluations (no response to voice, loss of eyelash reflexes, PSI ≤ 50) are positive. After that, propofol is not administered. During anesthesia induction, the concentration of the inhaled anesthetic is adjusted so that Psi is between 25-50, and the anesthesia process is the same for both groups. Continuously monitor blood pressure, pulse, and Psi, and record the MAC value of the inhaled anesthetic immediately after tracheal intubation, vital signs, and Psi. The raw data of EEG is stored through the Sedline sensor and additionally analyzed and evaluated. The primary endpoint is the dose of propofol administered until the response to the voice ("Open your eyes.") is absent

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
PROCEDURE	Binaural beat	Different frequencies are transmitted in both ears, causing beats. The low frequency sound generated by beats induces brainwaves entrainment.
PROCEDURE	Silent	Apply a wave file which is created in silence.

Timeline

• Start date: 2022-07-05
• Primary completion: 2023-09-07
• Completion: 2023-10-07
• First posted: 2022-06-24
• Last updated: 2023-08-15

Locations

1 site across 1 country: South Korea