Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values
研究概览
简要总结
Elderly patients with hip fracture are frail due to associated comorbidity. In these situations, regional anesthesia is recommended as it is associated to less postoperative cognitive dysfunction. However, hypotension during the process may impair ischemic cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and the administration of vasoactive drugs during the process can minimize these risks. Although bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the studies show conflicting results. The aim of this study is to investigate if there are clinically relevant differences between these two drugs in terms of hemodynamic parameters during the surgical process with special focus on the effects on regional cerebral oximetry and cognitive status after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 70 years old who undergo major surgery for hip fracture and will receive intrathecal anesthesia
- •Patients in which it is considered adequate, according to the usual clinical practice, the use of bupivacaine or levobupivacaine as part of the intrathecal anesthesia
- •Patients who give their informed consent to participate in the study
排除标准
- •Patients allergic to anesthetic drugs to be used in the protocol or to local anesthetics amida type.
- •Patients with severe aortic stenosis or hemodynamic instability.
- •Patients who refuse the anesthetic technique or contraindication for the use of the intrathecal technique.
- •Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors)
- •Patients in which the use of bupivacaine or levobupivacaine is contraindicated as part of the intrathecal anesthesia
- •Any condition that, in the investigator's opinion, could pose a risk to the patient
研究组 & 干预措施
Bupivacaine
Intrathecal administration of bupivacaine 0.5%
Doses:
Bupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Bupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.
干预措施: fentanyl 15 microg (Drug)
Bupivacaine
Intrathecal administration of bupivacaine 0.5%
Doses:
Bupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Bupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.
干预措施: Bupivacaine 7 mg (Drug)
Bupivacaine
Intrathecal administration of bupivacaine 0.5%
Doses:
Bupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Bupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.
干预措施: Bupivacaine 9 mg (Drug)
Levobupivacaine
Intrathecal administration of levobupivacaine 0.5%:
Doses:
Levobupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Levobupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.
干预措施: fentanyl 15 microg (Drug)
Levobupivacaine
Intrathecal administration of levobupivacaine 0.5%:
Doses:
Levobupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Levobupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.
干预措施: Levobupivacaine 7 mg (Drug)
Levobupivacaine
Intrathecal administration of levobupivacaine 0.5%:
Doses:
Levobupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Levobupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.
干预措施: Levobupivacaine 9 mg (Drug)
结局指标
主要结局
Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values
时间窗: Measured continuously during surgery (an expected average of 60 minutes)
次要结局
- Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test(7 days post surgery)
研究者
Diana L Fernandez Galinski
Physician - Anesthesiology
Corporacion Parc Tauli