瑞马唑仑用于腹腔镜子宫切除术患者的临床研究

Clinical trial of remimazolam in the treatment of patients undergoing laparoscopic hysterectomy

目的观察瑞马唑仑对在Trendelenburg体位下进行腹腔镜子宫切除术患者血流动力学的影响及诱导和维持阶段的麻醉效果。方法将择期气管插管全麻下腹腔镜子宫切除术患者分为对照组及试验组。对照组及试验组分别使用丙泊酚及瑞马唑仑进行静脉全身麻醉,麻醉全程监测脑电双频指数(BIS)值并根据BIS值调整药量,若麻醉效果不佳给予补救剂量。2组患者术中均于气腹建立后用Trendelenburg体位。记录2组患者的麻醉起效时间、苏醒时间、拔管时间及拔管后5 min Ramsay评分,比较2组患者麻醉诱导前(T_(0))、麻醉给药后(T_(1))、气管插管后1 min(T_(2))、气腹建立前(T_(3))、气腹建立且Trendelenburg位5 min(T_(4))、气腹手术30 min(T_(5))及气腹结束平卧位(T_(6))时平均动脉压(MAP)、心率(HR)、心输出量(CO)、体循环血管阻力(SVR)及BIS变化情况,评估围术期麻醉相关不良事件发生情况。结果对照组和试验组各入组41例。试验组和对照组T_(1)时MAP分别为(72.27±9.52)和(64.15±10.25)mmHg。试验组T_(1)~T_(6)时HR分别为(70.88±7.72)、(79.37±9.81)、(61.80±10.01)、(66.22±9.59)、(72.02±5.85)和(67.37±10.54)次/分;对照组分别为(62.01±6.81)、(67.15±9.80)、(55.02±5.28)、(54.70±7.21)、(56.27±7.34)和(54.76±5.71)次/分。试验组T_(2)~T_(6)时CO分别为(5.76±0.64)、(4.20±0.66)、(4.17±0.82)、(4.86±0.74)和(4.90±0.71)L·min^(-1);对照组分别为(5.08±1.64)、(3.90±0.68)、(3.52±1.00)、(3.80±0.73)和(4.40±1.01)L·min^(-1)。试验组T_(2)、T_(4)、T_(5)时SVR分别为(1252.02±226.30)、(1919.75±441.10)和(1642.71±331.20)dyne·s^(-1)·cm^(-5);对照组分别为(1437.76±275.80)、(2280.02±457.97)和(2052.93±373.05)dyne·s^(-1)·cm^(-5)。试验组苏醒时间、拔管时间和拔管后5 min Ramsay评分分别为(9.44±2.34)min、(11.02±2.56)min和(2.63±0.66)分;对照组分别为(10.46±2.33)min、(12.20±2.00)min和(3.07±0.78)分。试验组围术期麻醉相关不良事件发生率为17.07%,对照组为43.90%,以上差异均有统计学意义(均P<0.05)。结论瑞马唑仑对在Trendelenburg体位下进行腹腔镜子宫切除术患者血流动力学的影响较小,且麻醉效果与丙泊酚相当。

Objective To examine the hemodynamic and anesthetic effects of remimazolam in patients undergoing laparoscopic hysterectomy while in the Trendelenburg position.Methods The patients who underwent elective laparoscopic hysterectomy under general anesthesia were divided into control group and treatment group.The treatment group received remimazolam for intravenous general anesthesia,while the control group received propofol.The bispectral index(BIS)value was continuously monitored and the dosage was adjusted based on its value.If the anesthetic effect is not good,a remedial dose was given.Following the establishment of pneumoperitoneum,the Trendelenburg position was utilized in both groups.In both groups,we recorded the onset time of anesthesia,recovery time,extubation time,and the 5-minute Ramsay score after extubation.In this study,we compared the changes in mean arterial pressure(MAP),heart rate(HR),cardiac output(CO),systemic vascular resistance(SVR),and BIS between two groups at various time points.These time points included before anesthesia induction(T_(0)),after anesthesia administration(T_(1)),1 minute after tracheal intubation(T_(2)),before pneumoperitoneum establishment(T_(3)),5 min after pneumoperitoneum establishment and Trendelenburg position(T_(4)),30 min after pneumoperitoneum operation(T_(5)),and supine position at the end of pneumoperitoneum(T_(6)).The occurrence of perioperative anesthesia-related adverse events was evaluated.Results There were 41 patients treatment group and 41 patients in control group.At T_(1),the MAP in treatment group and control group were(72.27±9.52)and(64.15±10.25)mmHg.The HR of treatment group at T_(1)-T_(6) were(70.88±7.72),(79.37±9.81),(61.80±10.01),(66.22±9.59),(72.02±5.85)and(67.37±10.54)times·min^(-1),which in control group were(62.01±6.81),(67.15±9.80),(55.02±5.28),(54.70±7.21),(56.27±7.34)and(54.76±5.71)times·min^(-1).The cardiac output(CO)of treatment group at T_(2)-T_(6) were(5.76±0.64),(4.20±0.66),(4.17±0.82),(4.86±0.74)and(4.90±0.71)L·min^(-1),which in control group were(5.08±1.64),(3.90±0.68),(3.52±1.00),(3.80±0.73)and(4.40±1.01)L·min^(-1).The systemic vascular resistance(SVR)of the treatment group at T_(2),T_(4),and T_(5) were(1252.02±226.30),(1919.75±441.10)and(1642.71±331.20)dyne·s^(-1)·cm^(-5),while in control group were(1437.76±275.80),(2280.02±457.97)and(2052.93±373.05)dyne·s^(-1)·cm^(-5).The awaken time,extubation time and Ramsay score at 5 min after extubation in treatment group were(9.44±2.34)min,(11.02±2.56)min and 2.63±0.66,while in control group were(10.46±2.33)min,(12.20±2.00)min and 3.07±0.78.The incidence of adverse events related to perioperative anesthesia was 17.07%in the treatment group and 43.90%in the control group.The differences were all statistically significant(all P<0.05).Conclusion In patients undergoing laparoscopic hysterectomy in Trendelenburg position,remimazolam had a reduced impact on hemodynamics compared with propofol.However,its anesthetic effect is equivalent to propofol.