Zhao Xinmin, Xu Haigen, Wang Shuping, Chen Yuanyuan, Yue Shuyu
Department of Anesthesiology, Yancheng Maternal and Child Health Care Hospital Affiliated to Yangzhou University, Yancheng, Jiangsu Province, 224000, P. R. China.
BMC Anesthesiol. 2025 May 29;25(1):273. doi: 10.1186/s12871-025-03156-1.
Hypotension often occurs during intraoperative anesthesia induction in gynecological laparoscopic surgery. Remimazolam is reportedly associated with lesser intraoperative hypotension than propofol. This trial was conducted to evaluate the effect of propofol combined with remimazolam besylate on post-induction hypotension (PIH) in patients undergoing gynecological laparoscopic surgery.
All enrolled patients were randomly assigned to receive propofol (Group P), remimazolam besylate plus propofol (Group PR), or remimazolam besylate (Group R). Patients in group P received 2.0 mg/kg propofol, Sufentanil 0.4 μg/kg, and rocuronium bromide 0.8 mg/kg; Patients in group PR received remimazolam besylate 0.2 mg/kg, propofol 1.0 mg/kg, Sufentanil 0.4 μg/kg, and rocuronium bromide 0.8 mg/kg; Patients in group R received remimazolam besylate 0.4 mg/kg, Sufentanil 0.4 μg/kg, and rocuronium bromide 0.8 mg/kg; the anesthesia was maintained with propofol 4-10 mg/kg/h and remifentanil 0.1-0.3 μg/kg/min. The primary outcome was the incidence of hypotension after anesthesia induction. Hypotension was defined as a mean arterial pressure (MAP) reduced 30% or more from the baseline MAP value or MAP < 65 mmHg. Blood pressure was recorded five times during anesthesia. Time points T0, T1, T2, T3 and T4, were base line, before tracheal intubation, 1 min after tracheal intubation, 5 min after intubation, and immediately after surgical skin incision, respectively. The secondary outcomes were heart rate and bispectral index (BIS). Heart rate and BIS were measured from T0 to T4.
One hundred sixty-nine patients were included in this study. A total of 30 patients in the three groups developed hypotension after anesthesia induction, among which the incidence of PIH induced in group P was 31.6% (18/57), the incidence of PIH induced in group PR was 14.3% (8/56), and the incidence of PIH induced group R 7.1% (4/56), and there was a statistical difference in the incidence of PIH between the three groups (χ2 = 12.24, p = 0.0022). The heart rates in group R (70.53 ± 13.36 bpm, 88.48 ± 13.53 bpm, and 72.68 ± 13.42 bpm) were significantly higher than that in group P (63.68 ± 10.76 bpm, 80.25 ± 12.50 bpm, and 66.35 ± 11.56 bpm) at T1, T2 and T4 (p < 0.05, respectively). The heart rate in group R (88.48 ± 13.53 bpm) was significantly higher than that in group PR (80.00 ± 13.42 bpm) at T2 (p < 0.05). There was no statistically significant difference between group PR and group P (p > 0.05). BIS was significantly higher in group R than that in group P and in group PR at T3 and T4 (p < 0.05, respectively). There was no statistically significant difference between group PR and group P (p > 0.05).
Both Propofol plus remimazolam besylate and remimazolam besylate alone can reduce PIH, but propofol plus remimazolam besylate smooths the heart rate after general anesthesia undergoing gynecological laparoscopic.
This trial was retrospectively registered at http://www.chictr.org.cn (06/06/2024, ChiCTR-2400085401).
妇科腹腔镜手术中，术中麻醉诱导期间常发生低血压。据报道，与丙泊酚相比，瑞米唑仑引起的术中低血压较少。本试验旨在评估丙泊酚联合苯磺酸盐瑞米唑仑对妇科腹腔镜手术患者诱导后低血压（PIH）的影响。
所有入选患者随机分为接受丙泊酚组（P组）、苯磺酸盐瑞米唑仑加丙泊酚组（PR组）或苯磺酸盐瑞米唑仑组（R组）。P组患者接受2.0mg/kg丙泊酚、0.4μg/kg舒芬太尼和0.8mg/kg罗库溴铵；PR组患者接受0.2mg/kg苯磺酸盐瑞米唑仑、1.0mg/kg丙泊酚、0.4μg/kg舒芬太尼和0.8mg/kg罗库溴铵；R组患者接受0.4mg/kg苯磺酸盐瑞米唑仑、0.4μg/kg舒芬太尼和0.8mg/kg罗库溴铵；麻醉维持用4-10mg/kg/h丙泊酚和0.1-0.3μg/kg/min瑞芬太尼。主要结局是麻醉诱导后低血压的发生率。低血压定义为平均动脉压（MAP）较基线MAP值降低30%或更多或MAP＜65mmHg。麻醉期间记录5次血压。时间点T0、T1、T2、T3和T4分别为基线、气管插管前、气管插管后1分钟、插管后5分钟和手术皮肤切开后即刻。次要结局是心率和脑电双频指数（BIS）。从T0到T4测量心率和BIS。
本研究纳入169例患者。三组共有30例患者麻醉诱导后发生低血压，其中P组PIH发生率为31.6%（18/57），PR组PIH发生率为14.3%（8/56），R组PIH发生率为7.1%（4/56），三组PIH发生率有统计学差异（χ2 = 12.24，p = 0.0022）。R组在T1、T2和T4时的心率（70.53±13.36次/分、88.48±13.53次/分和72.68±13.42次/分）显著高于P组（63.68±10.76次/分、80.25±12.50次/分和66.35±11.56次/分）（p分别＜0.05）。R组在T2时的心率（88.48±13.53次/分）显著高于PR组（80.00±13.42次/分）（p＜0.05）。PR组和P组之间无统计学差异（p＞0.05）。R组在T3和T4时的BIS显著高于P组和PR组（p分别＜0.05）。PR组和P组之间无统计学差异（p＞0.05）。
丙泊酚加苯磺酸盐瑞米唑仑和单独使用苯磺酸盐瑞米唑仑均可降低PIH，但丙泊酚加苯磺酸盐瑞米唑仑可使妇科腹腔镜全麻后的心率更平稳。
本试验于http://www.chictr.org.cn进行回顾性注册（2024年6月6日，ChiCTR-2400085401）。
