Brainwave Entrainment During Emergence (BB_emergence)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, General
• Intervention / Treatment: Other: Binaural sound; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Binaural; Exposed to binaural sound (40 Hz) from the end of pneumoperitoneum until the eyes are open	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.
Active Comparator: Control; Applied silent files from the end of pneumoperitoneum until the eyes are open	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2023
• Primary Completion (Anticipated): November 15, 2023
• Study Completion (Anticipated): February 23, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: anesthesia; Brain Waves
• Other Study ID Numbers: 2212-028-1383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No