An interventional study of Binaural sound and Control in Anesthesia, General, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exposed to binaural sound (40 Hz) from the end of pneumoperitoneum until the eyes are open
Other: Binaural sound
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 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.
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.
Eye opening time
The time it takes to open patient's eyes in response to the voice after the anesthetic infusion is terminated.
Time frame: after the anesthetic infusion is terminated until 1 hour
Extubation time
The time it takes from the end of the anesthetic infusion to the extubation of endotracheal tube
Time frame: after the anesthetic infusion is terminated until 1 hour
Systolic blood pressure
Noninvasive systolic blood pressure
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Diastolic blood pressure
Noninvasive diastolic blood pressure
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Mean blood pressure
Noninvasive mean blood pressure
Time frame: from the end of the anesthetic infusion to the exit of operating room until 1 hour
Heart rate
Heart rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: When the patient stay in post-anesthesia care unit up to 1 hour
Plan to share: No
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Seoul National University Hospital