The Effect of Binaural Sound on Recovery of General Anesthesia in Patients Undergoing Laparoscopic Simple Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Eye opening time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Eye opening time
时间窗: 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.
次要结局
- Extubation time(after the anesthetic infusion is terminated until 1 hour)
- Heart rate(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- delta band activity(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- beta band activity(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- Postoperative recovery score(When the patient stay in post-anesthesia care unit up to 1 hour)
- Pain score(When the patient stay in post-anesthesia care unit up to 1 hour)
- Length of stay in post-anesthesia care unit(From entering to exit the post-anesthesia care unit up to 2 hours)
- Medication(When the patient stay in post-anesthesia care unit up to 1 hour)
- Diastolic blood pressure(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- alpha band activity(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- Systolic blood pressure(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- theta band activity(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- Rate of postoperative nausea and vomiting(When the patient stay in post-anesthesia care unit up to 1 hour)
- Mean blood pressure(from the end of the anesthetic infusion to the exit of operating room until 1 hour)
- Ramsay Sedation Scale(When the end of anesthesia within 5minutes)
研究者
Jeong-Hwa Seo
Professor
Seoul National University Hospital