BB: Effect of Binaural Beats for Maintenance of General Anesthesia
Study Details
Study Description
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:
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- Does applying binaural beats during surgery reduce the gas anesthetics (especially sevoflurane) requirement to maintaining adequate anesthetic depth during general anesthesia?
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- 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control In the control group, a silent state (a wave file made without sound) is applied via the sound generator and a headset, at the starting of general anesthesia induction. The sound generator volume is set to 60 dB. The sound generator and the headset is assigned after the randomization, and is blinded to the patient and the investigator. This sound is applied during the operation, and at the time of the final skin suture, the sound generator and the headset will be removed from the patient. |
Procedure: Silent
Apply wave file created in silence.
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| Experimental: Binaural Beat In the experimental group, the binaural beat which is produced by the beat of 1Hz difference is applied via the sound generator and a headset, at the starting of general anesthesia induction. The sound generator volume is set to 60 dB. The sound generator and the headset is assigned after the randomization, and is blinded to the patient and the investigator. This sound is applied during the operation, and at the time of the final skin suture, the sound generator and the headset will be removed from the patient. |
Procedure: Binaural beats
Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.
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Outcome Measures
Primary Outcome Measures
- Average end tidal sevoflurane concentration [From the starting of surgery to the final suture of skin]
Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure
Secondary Outcome Measures
- End tidal minimal alveolar concentration - Maximum [From the starting of surgery to the final suture of skin]
Maximal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
- End tidal minimal alveolar concentration - Minimum [From the starting of surgery to the final suture of skin]
Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
- Anxiety [Right after arriving the operating room]
Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), after entering the operating room
- Anxiety [Just before leaving the post anesthesia care unit]
Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), just before leaving the post anesthesia care unit
- Vital sign [From the starting to the end of general anesthesia]
Noninvasive blood pressure (systolic & diastolic & mean, mmHg)
- Vital sign [From the starting to the end of general anesthesia]
Heart rate (bpm)
- Vital sign [From the starting to the end of general anesthesia]
Saturation by pulse oximeter (%)
- Brain wave [From the starting of surgery to the final suture of skin]
Patient state index (PSI) by Sedline device
- Brain wave [From the starting of surgery to the final suture of skin]
brainwaves (raw data) which are collected in the Sedline device - alpha, beta, theta, delta, gamma brain wave
- Post operative nausea vomiting [During the patients stay in post anesthesia care unit]
The incidence of post operative nausea vomiting, in the post anesthesia care unit
- Post operative nausea vomiting [Since the patient leaves the post anesthesia care unit, until post operative 24 hours]
The incidence of post operative nausea vomiting, in the ward within 24 hours
- Post operative pain [While the patient stay in post anesthesia care unit]
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
- Post operative pain [24 hours after operation]
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
- Delirium [Since the patient leaves the post anesthesia care unit, until post operative 24 hours]
The incidence of delirium in the ward within 24 hours after operation
- Delirium [Since the patient leaves the post anesthesia care unit, until post operative 48 hours]
The incidence of delirium in the ward within 48 hours after operation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who are scheduled for thyroidectomy without neuromonitoring
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Patients aged 20-60 who require general anesthesia over 2 hours
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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
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Patients with ASA physical status classification 1-2
Exclusion Criteria:
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Patients with hearing loss or using hearing aids
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Patients who received narcotic analgesics or sedative drugs within 1 week
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Patients with alcohol or drug dependence
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Patients with drug hypersensitivity to sevoflurane
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Patients with family history or past history of malignant hyperthermia
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Patients with neuromuscular disease of myasthenia gravis
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Patients with arrhythmia, cardiovascular disease, and decreased heart function
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Patients with kidney failure
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Patients who are judged to be inappropriate for this clinical trial according to the opinions of investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Jeong-Hwa Seo, MD., PhD., Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
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- Wiwatwongwana D, Vichitvejpaisal P, Thaikruea L, Klaphajone J, Tantong A, Wiwatwongwana A; Medscape. The effect of music with and without binaural beat audio on operative anxiety in patients undergoing cataract surgery: a randomized controlled trial. Eye (Lond). 2016 Nov;30(11):1407-1414. doi: 10.1038/eye.2016.160. Epub 2016 Oct 14.
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