PDF(Pubmed)
Abstract：
BACKGROUND: To date, there is no standardized practice for the use of pharmacological sedatives during flexible bronchoscopy, particularly for elderly patients. This exploratory study aimed to assess the efficacy and safety of remimazolam at a single induced dose for deep sedation in elderly patients undergoing diagnostic flexible bronchoscopy (DFB), and compare with midazolam, a commonly used sedative.
METHODS: A total of 100 elderly patients (age range 65-80 yr; American Society of Anesthesiologists Physical Status I-III) undergoing DFB were randomly allocated into 2 groups according to the sedatives used for induction: the remimazolam group and the midazolam group. Sedation induction was initiated by an intravenous bolus of remimazolam (0.135 mg/kg) or midazolam (0.045 mg/kg), respectively, both groups were combined with a high-dose of alfentanil (18 µg/kg), and supplemented with high-flow nasal cannula (HFNC) oxygen supply at a flow rate of 45 L/min. If the target depth of sedation was not achieved, propofol would be titrated as a rescue. The primary outcome was the success rate of sedation at a single induced dose to achieve target depth (Ramsay sedation score [RSS] = 4) during induction, intraoperative changes in vital signs, postoperative follow-up situation and incidence of post-bronchoscopy adverse events were evaluated as secondary outcomes.
RESULTS: The success rate of sedation in the remimazolam group was significantly higher than that in the midazolam group (65.2% vs 39.6%, P = .013), while the incidence of extra sleep within 6 hours after procedure was lower in the remimazolam group as compared to the midazolam group (10.9% vs 31.3%, P = .016). No statistically significant differences were observed between the 2 groups regarding hemodynamic fluctuations, incidence of hypoxemia, and cough response during the procedure, as well as postoperative recall, willingness to undergo reexamination, and other post-bronchoscopy adverse events.
CONCLUSIONS: Bolus administration of remimazolam offers advantages over midazolam for deep sedation in elderly patients undergoing DFB, in terms of a higher success rate of sedation and a lower incidence of extra sleep within 6 hours after procedure, though the safety profiles of both groups were favorable.
METHODS: A total of 100 elderly patients (age range 65-80 yr; American Society of Anesthesiologists Physical Status I-III) undergoing DFB were randomly allocated into 2 groups according to the sedatives used for induction: the remimazolam group and the midazolam group. Sedation induction was initiated by an intravenous bolus of remimazolam (0.135 mg/kg) or midazolam (0.045 mg/kg), respectively, both groups were combined with a high-dose of alfentanil (18 µg/kg), and supplemented with high-flow nasal cannula (HFNC) oxygen supply at a flow rate of 45 L/min. If the target depth of sedation was not achieved, propofol would be titrated as a rescue. The primary outcome was the success rate of sedation at a single induced dose to achieve target depth (Ramsay sedation score [RSS] = 4) during induction, intraoperative changes in vital signs, postoperative follow-up situation and incidence of post-bronchoscopy adverse events were evaluated as secondary outcomes.
RESULTS: The success rate of sedation in the remimazolam group was significantly higher than that in the midazolam group (65.2% vs 39.6%, P = .013), while the incidence of extra sleep within 6 hours after procedure was lower in the remimazolam group as compared to the midazolam group (10.9% vs 31.3%, P = .016). No statistically significant differences were observed between the 2 groups regarding hemodynamic fluctuations, incidence of hypoxemia, and cough response during the procedure, as well as postoperative recall, willingness to undergo reexamination, and other post-bronchoscopy adverse events.
CONCLUSIONS: Bolus administration of remimazolam offers advantages over midazolam for deep sedation in elderly patients undergoing DFB, in terms of a higher success rate of sedation and a lower incidence of extra sleep within 6 hours after procedure, though the safety profiles of both groups were favorable.
摘要：
背景：迄今为止，在柔性支气管镜检查期间没有使用药物镇静剂的标准化实践，特别是老年患者。这项探索性研究旨在评估瑞马唑仑在接受诊断性软支气管镜检查（DFB）的老年患者中用于深度镇静的单一诱导剂量的有效性和安全性。与咪达唑仑相比，一种常用的镇静剂。
方法：将100名接受DFB的老年患者（年龄范围65-80岁；美国麻醉医师协会体格状态I-III）根据用于诱导的镇静剂随机分为2组：雷米马唑仑组和咪达唑仑组。通过静脉推注雷米马唑仑（0.135mg/kg）或咪达唑仑（0.045mg/kg）开始镇静诱导，分别,两组均联合使用高剂量的阿芬太尼（18µg/kg），并以45L/min的流速补充高流量鼻插管(HFNC)氧气供应。如果没有达到目标镇静深度,丙泊酚将被滴定作为抢救。主要结果是诱导过程中单次诱导剂量镇静达到目标深度的成功率（Ramsay镇静评分[RSS]=4）。术中生命体征的变化，术后随访情况和支气管镜检查后不良事件发生率作为次要结局进行评估.
结果：雷米马唑仑组的镇静成功率明显高于咪达唑仑组（65.2％vs39.6％，P=.013)，与咪达唑仑组相比，雷米马唑仑组术后6小时内额外睡眠的发生率较低（10.9％vs31.3％，P=.016）。两组在血流动力学波动方面无统计学差异。低氧血症的发生率，以及手术过程中的咳嗽反应,以及术后召回，愿意接受复查，和其他支气管镜检查后的不良事件。
结论：在接受DFB的老年患者中，雷米马唑仑的大剂量给药在深度镇静方面优于咪达唑仑。在手术后6小时内镇静成功率较高和额外睡眠发生率较低方面，尽管两组的安全性均良好。
方法：将100名接受DFB的老年患者（年龄范围65-80岁；美国麻醉医师协会体格状态I-III）根据用于诱导的镇静剂随机分为2组：雷米马唑仑组和咪达唑仑组。通过静脉推注雷米马唑仑（0.135mg/kg）或咪达唑仑（0.045mg/kg）开始镇静诱导，分别,两组均联合使用高剂量的阿芬太尼（18µg/kg），并以45L/min的流速补充高流量鼻插管(HFNC)氧气供应。如果没有达到目标镇静深度,丙泊酚将被滴定作为抢救。主要结果是诱导过程中单次诱导剂量镇静达到目标深度的成功率（Ramsay镇静评分[RSS]=4）。术中生命体征的变化，术后随访情况和支气管镜检查后不良事件发生率作为次要结局进行评估.
结果：雷米马唑仑组的镇静成功率明显高于咪达唑仑组（65.2％vs39.6％，P=.013)，与咪达唑仑组相比，雷米马唑仑组术后6小时内额外睡眠的发生率较低（10.9％vs31.3％，P=.016）。两组在血流动力学波动方面无统计学差异。低氧血症的发生率，以及手术过程中的咳嗽反应,以及术后召回，愿意接受复查，和其他支气管镜检查后的不良事件。
结论：在接受DFB的老年患者中，雷米马唑仑的大剂量给药在深度镇静方面优于咪达唑仑。在手术后6小时内镇静成功率较高和额外睡眠发生率较低方面，尽管两组的安全性均良好。
