Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China.
BMC Anesthesiol. 2024 Oct 8;24(1):360. doi: 10.1186/s12871-024-02746-9.
A combination of remimazolam and propofol could produce more stable sedation. A good medication regimen should consider not only efficacy but also safety, especially hypotension. The aim of the current study was to compare the incidence and amount of hypotension by propofol versus remimazolam-propofol combinations in day-surgery hysteroscopy.
Patients were randomly assigned to receive either propofol (Group P, n = 125) or remimazolam-propofol combinations (Group RP, n = 125) at a 1:1 ratio. Intravenous injection of sufentanil 0.1ug/kg were administered before sedative medication. In group P, a bolus of 2.5 mg/kg propofol was administered. In group RP, intravenous anesthesia was commenced with 0.125 mg/kg remimazolam and 1 mg/kg propofol. After loss of consciousness, propofol was maintained at 6 mg/kg/h. The primary outcomes were the incidence and amount of hypotension during surgery. Hypotension was defined as a MAP less than 65mmHg for at least 1 min. The amount of hypotension was assessed by time-weighted average intraoperative MAP under a threshold of 65 mmHg. The secondary outcomes were various anesthesia related parameters and some adverse events.
In group P, 25 patients (20.0%) experienced hypotension during hysteroscopy compared with 9 patients (7.2%) in group RP, for a difference of 12.8% (RR 2.778, 95%CI [1.352-5.709]). The combination of remimazolam and propofol resulted in significantly lower TWA (Time Weighted Average) threshold 0.14 (0.10-0.56) mmHg in group RP compared to 0.31 (0.15-0.67) mmHg in group P. The total dose of propofol was nearly double in group P compared to group RP. A significantly higher frequency of injection pain and low oxygen saturation was observed in the group P than that of the group RP. Hiccup was observed only in group RP. The incidences of body movement, bradycardia and vomiting were no significant difference between groups.
The incidence and amount of hypotension by remimazolam-propofol combinations was significantly less than that by propofol sedation in day-surgery hysteroscopy. The optimization of medication regimen would attenuate the harm of hypotension and contribute to patients' rapid recovery in day surgery.
Chinese Clinical Trial Registry, ChiCTR2400079888 (date: 15/01/2024).
咪达唑仑和丙泊酚的联合使用可以产生更稳定的镇静效果。一个好的药物治疗方案不仅要考虑疗效，还要考虑安全性，尤其是低血压。本研究的目的是比较丙泊酚与咪达唑仑-丙泊酚联合用于日间手术宫腔镜检查时低血压的发生率和程度。
患者被随机分为丙泊酚组（P 组，n=125）和咪达唑仑-丙泊酚组（RP 组，n=125），比例为 1:1。在镇静药物给药前静脉注射舒芬太尼 0.1ug/kg。在 P 组中，给予 2.5mg/kg 丙泊酚推注。在 RP 组中，静脉麻醉起始剂量为 0.125mg/kg 咪达唑仑和 1mg/kg 丙泊酚。意识丧失后，以 6mg/kg/h 的速度维持丙泊酚输注。主要结局是手术期间低血压的发生率和程度。低血压定义为至少 1 分钟内 MAP 低于 65mmHg。通过时间加权平均术中 MAP 低于 65mmHg 的阈值来评估低血压的程度。次要结局是各种麻醉相关参数和一些不良反应。
P 组有 25 例（20.0%）患者在宫腔镜检查期间发生低血压，而 RP 组有 9 例（7.2%）患者发生低血压，差异为 12.8%（RR 2.778，95%CI [1.352-5.709]）。与 P 组相比，RP 组咪达唑仑和丙泊酚联合使用时，TWA（Time Weighted Average）阈值显著降低，为 0.14（0.10-0.56）mmHg，而 P 组为 0.31（0.15-0.67）mmHg。P 组丙泊酚的总剂量几乎是 RP 组的两倍。P 组注射疼痛和低氧饱和度的发生率明显高于 RP 组。仅在 RP 组观察到呃逆。两组之间的体动、心动过缓和呕吐发生率无显著差异。
在日间手术宫腔镜检查中，咪达唑仑-丙泊酚联合使用的低血压发生率和程度明显低于丙泊酚镇静。优化药物治疗方案可以减轻低血压的危害，促进日间手术患者的快速康复。
中国临床试验注册中心，ChiCTR2400079888（日期：2024 年 1 月 15 日）。
