Brainwave Entrainment During Emergence

Anesthesia, General Clinical Trial

— BB_emergence  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05736510
• Other study ID #: 2212-028-1383
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: Jeong-Hwa Seo, MD.,PhD.
• Phone: +82-10-55020551
• Email: eongpa[@]empas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: February 23, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Other:
• Binaural sound
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.
• Control
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Ozkose 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Systolic blood pressure	Noninvasive systolic blood pressure	from the end of the anesthetic infusion to the exit of operating room until 1 hour
Secondary	Diastolic blood pressure	Noninvasive diastolic blood pressure	from the end of the anesthetic infusion to the exit of operating room until 1 hour
Secondary	Mean blood pressure	Noninvasive mean blood pressure	from the end of the anesthetic infusion to the exit of operating room until 1 hour
Secondary	Heart rate	Heart rate	from the end of the anesthetic infusion to the exit of operating room until 1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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