Effects of Continuous Versus Single Dose Spinal Anesthesia in Octagenerians Undergoing Hip Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of hypotension
研究概览
简要总结
Continuous spinal anesthesia (CSA) is an anesthetic technique that offers several clinical advantages for anesthesia and analgesia in elderly patients. The level of sensory blockade can be titrated to the desired dermatomal level with great precision with intrathecal (IT) catheters, allowing better control of the hemodynamic consequences of sympathetic blockade associated with spinal anesthesia compared to epidural or single shot spinal techniques. Better control of hemodynamics maybe advantageous in patients with cardiac disease in whom administration of lower doses of local anesthetics is advantageous. Greater numbers of patients are presenting for surgery with aging-related pre-existing conditions, which places them at greater risk of an adverse outcome, such as cardiac or pulmonary disease or diabetes mellitus. CSA allows incremental dosing of an intrathecal local anesthetic providing fewer hemodynamic alterations. While spinal anesthesia is widely used anesthetic technique in lower limb surgery in the elderly, it induces more hemodynamic instability due to high blockage effect which largely limits the use of conventional dose of spinal anesthesia in high risk elderly patients
详细描述
METHODOLOGY:
Patients and Method. Type of Study: Randomized controlled clinical trial. Approval will be obtained from the research ethics committee of Faculty of Medicine; Ain Shams University and a written informed consent will be taken from each patient to participate in the study. Study Setting: Ain-shams University Hospitals, Cairo, Egypt. Study Period: 6 months from approval of medical ethics committee. Sample Size: Based on the study of continuous spinal Anestheisa by Vincent M, Olivier F, and David G, 2006 assuming a rate of hypotension attacks (20% of the baseline blood pressure) of 15% in CSA group compared to 65% in SD spinal anesthesia group, a sample of 20 patients in each group is enough to detect such METHODOLOGY: Patients and Method. Type of Study: Randomized controlled clinical trial. Approval will be obtained from the research ethics committee of Faculty of Medicine; Ain Shams University and a written informed consent will be taken from each patient to participate in the study.METHODOLOGY:
Patients and Method. Type of Study: Randomized controlled clinical trial.
Study Setting: Ain-shams University Hospitals, Cairo, Egypt. Study Period: 6 months from approval of medical ethics committee. Sample Size: Based on the study of continuous spinal Anestheisa by Vincent M, Olivier F, and David G, 2006 (3) assuming a rate of hypotension attacks (20% of the baseline blood pressure) of 15% in CSA group compared to 65% in SD spinal anesthesia group, a sample of 20 patients in each group is enough to detect such difference, at 0.05 alpha error and 80% power of the test. Study tool: Visual Analogue Scale (VAS)
Study Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 80 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Either sex
- •80 to 89 years of age
- •undergoing hip surgery
排除标准
- •Patient refusal of procedure or participation in the study.
- •Cardiac patients diagnosed with sever Aortic stenosis defined by echo as AVA (aortic valve area) < 1cm and MPG (mean pressure gradient ) >40mmHg.
- •Patients with hemodynamic instability.
- •Preexisting infection at the block site.
- •Allergy to local anesthetics.
- •Psychiatric illness.
- •Increased intracranial tension.
- •Patients with coagulopathy problems.
结局指标
主要结局
Incidence of hypotension
时间窗: Intraoperative and up to 12 hours postoperative
to compare the The incidence of hypotension (defined as decrease in blood pressure 20% from the base line) in continuous spinal anesthesia CSA versus single dose spinal anesthesia in octogenarians undergoing hip surgery
次要结局
- Total use of vasopressor(Intraoperative)
- Spinal anesthesia complications(Intraoperative and up to 12 hours postoperative)