PDF(Pubmed)
Abstract：
BACKGROUND: Spinal anesthesia (SA) is a conventional method for proper nerve block in abdominopelvic and lower extremity surgeries. Compared to general anesthesia, SA has reduced perioperative complications significantly. The hyperbaric type of bupivacaine hydrochloride (HB) induces spinal anesthesia more efficiently with a lower incidence of life-threatening adverse reactions like Perioperative hemodynamic changes and respiratory depression. More investigations are needed to define the best dosage that provides adequate anesthesia while reducing adverse effects for each surgical procedure.
METHODS: This double-blinded randomized clinical trial compared the consequences of the (12.5mg,15mg,20mg) dosages of HB-bupivacaine in elective lower limb orthopedic surgery. Using block randomization, we allocated 60 participants to three (n = 20) study groups. Utilizing the same protocol of anesthesia induction, outcome variables assumed and measured as the incidence of the adverse effects (Hypotension, Anxiety, Bradycardia, Nausea and Vomiting(N/V), Hypoventilation, and Decreased o2 saturation), and the requirement for intervention to control the unwanted reaction. Addressing that, outcome variables were measured 10 times perioperatively. One-way ANOVA test, the chi2 test, or repeated measures ANOVA test with the Bonferroni adjustment were utilized as appropriate.
RESULTS: We found that the incidence of hypotension (P-value:0.02) and the N/V (P-value < 0.001) are associated with the HB-bupivacaine dosage. Contrary, our findings indicate that the incidence of apnea, bradycardia, and hypoventilation did not exhibit a significant dose-dependent pattern between the groups. Repeated measures analysis revealed significant intergroup differences for Herat rate, systolic, diastolic, and mean arterial pressure (group*time Pvalue < 0.001). The observed differences were more prominent 10-30 min after injection of HB-bupivacaine. The regression model claimed that gender (P-value:0.002) and drug dosage (P-value:0.03) significantly predict the incidence of adverse effects.
CONCLUSIONS: Our results, suggest that the administration of the 12.5mg HB-bupivacaine provides adequate anesthesia while minimizing the risk of adverse events for lower limb orthopedic surgeries lasting up to 180 min.
BACKGROUND: The study was registered at the Clinical Trial Registry Center (IRCT20160202026328N7), Registered on 2022.01.10.
METHODS: This double-blinded randomized clinical trial compared the consequences of the (12.5mg,15mg,20mg) dosages of HB-bupivacaine in elective lower limb orthopedic surgery. Using block randomization, we allocated 60 participants to three (n = 20) study groups. Utilizing the same protocol of anesthesia induction, outcome variables assumed and measured as the incidence of the adverse effects (Hypotension, Anxiety, Bradycardia, Nausea and Vomiting(N/V), Hypoventilation, and Decreased o2 saturation), and the requirement for intervention to control the unwanted reaction. Addressing that, outcome variables were measured 10 times perioperatively. One-way ANOVA test, the chi2 test, or repeated measures ANOVA test with the Bonferroni adjustment were utilized as appropriate.
RESULTS: We found that the incidence of hypotension (P-value:0.02) and the N/V (P-value < 0.001) are associated with the HB-bupivacaine dosage. Contrary, our findings indicate that the incidence of apnea, bradycardia, and hypoventilation did not exhibit a significant dose-dependent pattern between the groups. Repeated measures analysis revealed significant intergroup differences for Herat rate, systolic, diastolic, and mean arterial pressure (group*time Pvalue < 0.001). The observed differences were more prominent 10-30 min after injection of HB-bupivacaine. The regression model claimed that gender (P-value:0.002) and drug dosage (P-value:0.03) significantly predict the incidence of adverse effects.
CONCLUSIONS: Our results, suggest that the administration of the 12.5mg HB-bupivacaine provides adequate anesthesia while minimizing the risk of adverse events for lower limb orthopedic surgeries lasting up to 180 min.
BACKGROUND: The study was registered at the Clinical Trial Registry Center (IRCT20160202026328N7), Registered on 2022.01.10.
摘要：
背景：脊椎麻醉（SA）是在腹骨盆和下肢手术中进行适当神经阻滞的常规方法。与全身麻醉相比，SA显著减少了围手术期并发症。高压型盐酸布比卡因（HB）可更有效地诱导脊髓麻醉，而危及生命的不良反应（例如围手术期血流动力学变化和呼吸抑制）的发生率较低。需要更多的研究来确定提供足够麻醉的最佳剂量，同时减少每次外科手术的不良反应。
方法：这项双盲随机临床试验比较了（12.5mg，15mg,20mg）剂量的HB-布比卡因在择期下肢骨科手术中的应用。使用块随机化，我们将60名参与者分配到3个研究组(n=20).利用相同的麻醉诱导方案，结果变量假定并测量为不良反应的发生率(低血压，焦虑,心动过缓,恶心和呕吐（N/V），通气不足,并降低O2饱和度)，以及控制不必要反应的干预要求。解决这个问题，围手术期测量结果变量10次.单因素方差分析测试,chi2测试，适当时使用带有Bonferroni调整的重复测量ANOVA检验。
结果：我们发现低血压的发生率（P值：0.02）和N/V（P值<0.001）与HB-布比卡因的剂量有关。相反，我们的研究结果表明呼吸暂停的发生率,心动过缓,和低通气组之间没有显著的剂量依赖性模式.重复测量分析显示赫拉特比率的显著组间差异，收缩压,舒张压,和平均动脉压（组*时间P值<0.001）。观察到的差异在注射HB-布比卡因后10-30分钟更为突出。回归模型认为性别(P值:0.002)和药物剂量(P值:0.03)显著预测不良反应的发生率。
结论：我们的结果，提示12.5mgHB-布比卡因的给药可提供足够的麻醉,同时将下肢骨科手术持续180分钟的不良事件风险降至最低.
背景：该研究已在临床试验注册中心（IRCT20160202026328N7）注册，于2022.01.10注册。
方法：这项双盲随机临床试验比较了（12.5mg，15mg,20mg）剂量的HB-布比卡因在择期下肢骨科手术中的应用。使用块随机化，我们将60名参与者分配到3个研究组(n=20).利用相同的麻醉诱导方案，结果变量假定并测量为不良反应的发生率(低血压，焦虑,心动过缓,恶心和呕吐（N/V），通气不足,并降低O2饱和度)，以及控制不必要反应的干预要求。解决这个问题，围手术期测量结果变量10次.单因素方差分析测试,chi2测试，适当时使用带有Bonferroni调整的重复测量ANOVA检验。
结果：我们发现低血压的发生率（P值：0.02）和N/V（P值<0.001）与HB-布比卡因的剂量有关。相反，我们的研究结果表明呼吸暂停的发生率,心动过缓,和低通气组之间没有显著的剂量依赖性模式.重复测量分析显示赫拉特比率的显著组间差异，收缩压,舒张压,和平均动脉压（组*时间P值<0.001）。观察到的差异在注射HB-布比卡因后10-30分钟更为突出。回归模型认为性别(P值:0.002)和药物剂量(P值:0.03)显著预测不良反应的发生率。
结论：我们的结果，提示12.5mgHB-布比卡因的给药可提供足够的麻醉,同时将下肢骨科手术持续180分钟的不良事件风险降至最低.
背景：该研究已在临床试验注册中心（IRCT20160202026328N7）注册，于2022.01.10注册。
