Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia During Hip Surgery in Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia
研究概览
简要总结
The frequency of hypotension is increased in geriatric patients due to physiological changes compared to the normal population. In this study, our aim is to compare the hemodynamic changes in geriatric patients undergoing hip surgery under spinal anesthesia with hypobaric and hyperbaric bupivacaine.
详细描述
Patients will be randomly assigned to one of two groups: HypoB (% 0.5 bupivacaine 3cc+ 2cc distilled water) or HyperB (% 0.5 bupivacaine 3cc+ 2cc %10 dextrose). For pre-positioning analgesia, an intravenous dose of fentanyl at 0.5 mcg/kg will be administered. Patients will then be positioned in the appropriate lateral decubitus position based on whether hypobaric or hyperbaric bupivacaine is used. Spinal anesthesia will be performed using 3 cc local anesthetic solution, followed by 15 minutes of lateralization.
During the surgery, hemodynamic parameters, sensory block levels at the 5th, 10th, 15th, and 20th minutes at lateral and supine position, and motor block levels with bromage scale at the 15th and 20th minutes at supine position will be recorded. The spread of the block to the T8 dermatome level was considered an indicator of a successful block. Hemodynamic parameters (blood pressure, heart rate, peripheral oxygen saturation) will be recorded at 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, and 120 minutes intraoperatively. Patients will receive crystalloid infusion at a rate of 5-7 ml/kg per hour throughout the procedure. The volume of intraoperative bleeding, the amount of blood products administered, and the doses of ephedrine, atropine, and noradrenaline used will also be documented. If the heart rate falls below 45 beats per minute, 0.5 mg of intravenous atropine will be administered.
A decrease in blood pressure of 20% or more from baseline will be defined as hypotension. In such cases, ephedrine will be administered. If hypotension persists despite a total dose of 20 mg ephedrine, a noradrenaline infusion will be initiated.
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
- •Patients over 65 years of age
- •Patients taken to surgery in a supine position due to femur fractures
- •Patients classified as ASA (American Society of Anesthesiologists) class I-III
排除标准
- •History of allergy to the drug
- •Patients with coagulopathy
- •Patients refusing to participate in the study
- •Severe valve stenosis
- •Infection at the injection site
- •Inadequate spinal anesthesia level during surgery
研究组 & 干预措施
HypoB
In the HypoB group, spinal anesthesia will be administered intrathecally using 3 cc of hypobaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned upward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data , bilateral sensory and motor block levels will be recorded.
干预措施: spinal anesthesia (Procedure)
HyperB
In the HyperB group, spinal anesthesia will be administered intrathecally using 3 cc of hyperbaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned downward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data, bilateral sensory, and motor block levels will be recorded.
干预措施: spinal anesthesia (Procedure)
结局指标
主要结局
Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia
时间窗: 2 hour
blood pressure monitoring
次要结局
- Evaluation of sensorial block with hypobaric and hyperbaric bupivacaine in spinal anesthesia(2 hour)
- Evaluation of motor block with hypobaric and hyperbaric bupivacaine in spinal anesthesia(2 hour)
研究者
Fadime Alagaş
Research assistant
Eskisehir Osmangazi University
