NCT05736510

Brainwave Entrainment During Emergence

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-11-15
• Completion: 2024-02-23
• First posted: 2023-02-21
• Last updated: 2023-02-21

Locations

1 site across 1 country: South Korea