Isobaric Ropivacaine 15 mg Versus Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Geriatric Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Changes in the extent and duration of sensory block
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing lower limb orthopedic surgery.
详细描述
52 patients physical status II-III according to the American Society of Anesthesiologists classification aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.
Patients were randomly assigned into two equal groups of 26 patients each according to the type of local anesthetic injected in the subarachnoid space , Group I : patients who received an intrathecal injection of 12.5 mg of 0.5% hyperbaric bupivacaine , Group II: patients who received an intrathecal injection of 15 mg of 0.5% ropivacaine.
The investigators compared both groups as regards the extent and duration of sensory and motor block and hemodynamics including heart rate (HR) , non invasive mean arterial blood pressure (MAP) and respiratory depression.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status II-III aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.
排除标准
- •Known hypersensitivity to amide local anesthetics and contraindications to spinal anesthesia.
研究组 & 干预措施
Hyperbaric bupivacaine
12.5 mg of 0.5% hyperbaric bupivacaine
干预措施: Hyperbaric bupivacaine (Drug)
Isobaric ropivacaine
15 mg of 0.5% isobaric ropivacaine
干预措施: Isobaric ropivacaine (Drug)
结局指标
主要结局
Changes in the extent and duration of sensory block
时间窗: within 2 years
The assessment of sensory block to pinprick was performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection and then every 15 min until regression to L5. Results of the pinprick test were determined bilaterally at midclavicular level by using a short-beveled 27-gauge needle. Response to pain we determined by asking the patient whether or not he feels pain with the pinprick.
Changes in the extent and duration of motor block
时间窗: within 2 years
Motor block in the lower limb was assessed by using a modified Bromage scale (0 = no paralysis , 1 = unable to raise extended leg , 2 = unable to flex knee , 3 = unable to flex ankle). These assessments were performed immediately after the assessments of sensory block until the return of normal motor function.
Changes in the heart rate
时间窗: within 2 years
All patients of these 2 groups were assessed and monitored for Haemodynamics using ECG for heart rate (HR). Baseline values were defined as heart rate values before the preanesthetic infusion. The values were recorded before the induction and then every 5 min until discharge from the recovery room.
Changes in the non invasive mean arterial blood pressure
时间窗: within 2 years
All patients of these 2 groups were assessed and monitored for Haemodynamics as regards non invasive mean arterial blood pressure (MAP). Baseline values were defined as blood pressure values before the preanesthetic infusion. The values were recorded before the induction and then every 5 min until discharge from the recovery room.
Respiratory depression
时间窗: within 2 years
Respiratory depression (defined as respiratory rate \< 8 min and SPO 2 \< 90%)
次要结局
未报告次要终点
研究者
Mohamed Sayed Mohamed Abbas
Doctor
Al Mouwasat Hospital