Anesthesia, GeneralBB_emergenceNCT05736510
Brainwave Entrainment During Emergence
A study testing Binaural sound in people with Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Binaural sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2023to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Binaural Sound on Recovery of General Anesthesia in Patients Undergoing Laparoscopic Simple Gynecological Surgery
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.
Read the detailed description
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.
- Conditions
- Anesthesia, General
- Being tested
- Binaural sound, Control
- Keywords
- Brain Waves, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural soundOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Binaural | Experimental | Exposed to binaural sound (40 Hz) from the end of pneumoperitoneum until the eyes are open Receives: Other: Binaural sound |
| Control | Active comparator | Applied silent files from the end of pneumoperitoneum until the eyes are open Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye opening time
The time it takes to open patient's eyes in response to the voice after the anesthetic infusion is terminated.
Measured: after the anesthetic infusion is terminated until 1 hour
Secondary outcomes (15)
Extubation time
The time it takes from the end of the anesthetic infusion to the extubation of endotracheal tube
Measured: after the anesthetic infusion is terminated until 1 hour
Systolic blood pressure
Noninvasive systolic blood pressure
Measured: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Diastolic blood pressure
Noninvasive diastolic blood pressure
Measured: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Mean blood pressure
Noninvasive mean blood pressure
Measured: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Heart rate
Heart rate
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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")
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: When the patient stay in post-anesthesia care unit up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion23 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment A prospective randomized study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
- Investigators
- Jeong-Hwa Seo, MD.,PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736510
- Sponsor's protocol ID
- 2212-028-1383
- Acronym
- BB_emergence
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmid W, Marhofer P, Opfermann P, Zadrazil M, Kimberger O, Triffterer L, Marhofer D, Klug W. Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):330-335. doi: 10.1016/j.bja.2020.05.050. Epub 2020 Jul 8.
PubMed 32653082Ozkose Z, Yalcin Cok O, Tuncer B, Tufekcioglu S, Yardim S. Comparison of hemodynamics, recovery profile, and early postoperative pain control and costs of remifentanil versus alfentanil-based total intravenous anesthesia (TIVA). J Clin Anesth. 2002 May;14(3):161-8. doi: 10.1016/s0952-8180(01)00368-3.
PubMed 12031745
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Binaural Sound on Recovery of General Anesthesia in Patients Undergoing Laparoscopic Simple Gynecological Surgery
- ClinicalTrials.gov ID
- NCT05736510
- Acronym / sponsor ID
- BB_emergence / 2212-028-1383
- Conditions
- Anesthesia, General
- Keywords
- Brain Waves, anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 23 Feb 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment A prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Binaural | Experimental | Other: Binaural soundExposed to binaural sound (40 Hz) from the end of pneumoperitoneum until the eyes are open |
| Control | Active comparator | Other: ControlApplied silent files from the end of pneumoperitoneum until the eyes are open |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural soundWhen 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. | Other | Binaural |
| ControlWhen 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. | Other | Control |
Primary outcome
Eye opening time
Time frame: after the anesthetic infusion is terminated until 1 hour
The time it takes to open patient's eyes in response to the voice after the anesthetic infusion is terminated.
15 secondary outcomes
Extubation time
Time frame: after the anesthetic infusion is terminated until 1 hour
Systolic blood pressure
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Diastolic blood pressure
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Mean blood pressure
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Heart rate
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
alpha band activity
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
beta band activity
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
theta band activity
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
delta band activity
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Ramsay Sedation Scale
Time frame: When the end of anesthesia within 5minutes
Postoperative recovery score
Time frame: When the patient stay in post-anesthesia care unit up to 1 hour
Pain score
Time frame: When the patient stay in post-anesthesia care unit up to 1 hour
Rate of postoperative nausea and vomiting
Time frame: When the patient stay in post-anesthesia care unit up to 1 hour
Length of stay in post-anesthesia care unit
Time frame: From entering to exit the post-anesthesia care unit up to 2 hours
Medication
Time frame: When the patient stay in post-anesthesia care unit up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 32653082Schmid W, Marhofer P, Opfermann P, Zadrazil M, Kimberger O, Triffterer L, Marhofer D, Klug W. Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):330-335. doi: 10.1016/j.bja.2020.05.050. Epub 2020 Jul 8.
- Background: PubMed 12031745Ozkose Z, Yalcin Cok O, Tuncer B, Tufekcioglu S, Yardim S. Comparison of hemodynamics, recovery profile, and early postoperative pain control and costs of remifentanil versus alfentanil-based total intravenous anesthesia (TIVA). J Clin Anesth. 2002 May;14(3):161-8. doi: 10.1016/s0952-8180(01)00368-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Hwa Seo, MD.,PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural sound in people with Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Hwa Seo, MD.,PhD. (+82-10-55020551, eongpa@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye opening time (time frame: after the anesthetic infusion is terminated until 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05736510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.