CAJ | 학술논문

目的：评估BIS监测在丙泊酚全凭静脉麻醉（total intravenous anesthesia, TIVA）下预防术中知晓的作用，探讨术中知晓的可能原因。方法采用多中心、大样本、前瞻性的随机、双盲、分组对照研究方法，患者（年龄≥16岁）被随机分为BIS监测指导组（A组，监测并维持BIS值40～60）和对照组（B组，监测BIS但遮挡显示屏）。分别于术后第1天和第4天随访，由独立的评估委员会作明确和可疑知晓的判断。术后间隔一定时间导出BIS数据，分析明确知晓病例的BIS趋势以判断是否存在浅麻醉。明确两组知晓的发生率。结果共收集5228例有效病例，其中A组2919例，B组2309例。明确知晓病例A组4例（0.14%），B组15例（0.65%），两组比较差异有统计学意义（P=0.002，OR=0.21，95%置信区间：0.07～0.63）。两组可疑知晓（A组0.14%，B组0.26%，P=0.485）和做梦（A组3.1%，B组3.1%，P=0.986）的发生率差异无统计学意义。19例明确知晓病例的术中BIS趋势和麻醉总结显示，8例（A组3例，B组5例）无BIS及知晓原因分析；6例获取了相应的BIS趋势图，其中5例（A组1例，B组4例）BIS趋势提示有明确浅麻醉表现，1例（B组）BIS基本稳定于60及以下；其余5例（B组）知晓经主管麻醉医生回顾，有术中浅麻醉和BIS波动且升高>60的情况。结论行BIS监测并维持BIS值40～60可有效减少TIVA术中知晓的发生。发生知晓的主要原因为术中浅麻醉。
목적：평고BIS감측재병박분전빙정맥마취（total intravenous anesthesia, TIVA）하예방술중지효적작용，탐토술중지효적가능원인。방법채용다중심、대양본、전첨성적수궤、쌍맹、분조대조연구방법，환자（년령≥16세）피수궤분위BIS감측지도조（A조，감측병유지BIS치40～60）화대조조（B조，감측BIS단차당현시병）。분별우술후제1천화제4천수방，유독립적평고위원회작명학화가의지효적판단。술후간격일정시간도출BIS수거，분석명학지효병례적BIS추세이판단시부존재천마취。명학량조지효적발생솔。결과공수집5228례유효병례，기중A조2919례，B조2309례。명학지효병례A조4례（0.14%），B조15례（0.65%），량조비교차이유통계학의의（P=0.002，OR=0.21，95%치신구간：0.07～0.63）。량조가의지효（A조0.14%，B조0.26%，P=0.485）화주몽（A조3.1%，B조3.1%，P=0.986）적발생솔차이무통계학의의。19례명학지효병례적술중BIS추세화마취총결현시，8례（A조3례，B조5례）무BIS급지효원인분석；6례획취료상응적BIS추세도，기중5례（A조1례，B조4례）BIS추세제시유명학천마취표현，1례（B조）BIS기본은정우60급이하；기여5례（B조）지효경주관마취의생회고，유술중천마취화BIS파동차승고>60적정황。결론행BIS감측병유지BIS치40～60가유효감소TIVA술중지효적발생。발생지효적주요원인위술중천마취。
Objective To evaluate the efficacy of bispectral index (BIS) monitoring on preventing awareness in pa-tients undergoing total intravenous anesthesia (TIVA), and determine the reasons for awareness by analyzing the intra-oper-ative BIS values of awareness cases. Methods This study was a prospective, randomized, double-blinded, multicentre controlled trial. Patients (≥16 years old) undergoing TIVA were randomly assigned to BIS-guided group (Group A, monitored and maintained BIS between 40~60 intra-operatively) and the control group (Group B, monitored BIS but the screen was covered). Blinded observer interviewed the patients for awareness at the 1st and 4th day after surgery. An inde-pendent evaluating committee assessed the results and identified the confirmed or possible awareness cases. The intraoper-ative BIS values were downloaded and the BIS trends of confirmed awareness cases were analyzed to determine whether in-adequate anesthesia existed. The primary outcome of the study was the incidence of confirmed awareness. Results Of the total 5 228 cases, 2 919 patients in the BIS group and 2 309 in the control group were included in the statistical analysis. Four confirmed awareness (0.14%) were reported in the BIS group and 15 confirmed awareness (0.65%) in the control group (P=0.002, OR=0.21, 95%CI:0.07~0.63), BIS-guided TIVA reduced the incidence of awareness by 78%. The inci-dences of possible awareness (0.14% vs. 0.26%, P= 0.485) and dreaming (3.1% vs. 3.1%, P= 0.986) were comparable between the BIS-guided group and the control group. Among the total 19 confirmed awareness patients, BIS trend of 8 cases (3 cases in Group A and 5 cases in Group B) was unavailable. Apart from these cases, 6 cases were identified to have intra-operative BIS trends, 5 of whom (4 cases in Group B, 1 case in Group A) showed BIS>60 and lasted for 19~106 min, whereas BIS trend in the other 1 case (Group B) was stable and BIS values were within 60 during the operation. Another 5 awareness cases (all in Group B) were reviewed by the responsible anesthesiologists, of which BIS values fluctu-ated and raised above 60 or improper anesthesia were confirmed. Conclusion Monitoring and maintaining BIS between 40~60 can decrease the risk of awareness in patients undergoing TIVA. The main reason for awareness is light anesthesia.