The Effects of Lateral Decubitus Positioning After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients Undergoing Lower Extremity Orthopedic Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Incidence of Hypotension
研究概览
简要总结
Spinal anesthesia is a common and preferred anesthetic technique for lower extremity orthopedic surgery in elderly patients. However, it can cause a significant drop in blood pressure (hypotension), especially in high-risk older patients with multiple medical conditions. This complication can lead to serious consequences such as heart attack, stroke, or death in vulnerable patients.
This study investigates whether keeping patients in a lateral (side-lying) position for 15 minutes after spinal anesthesia - instead of immediately turning them onto their back (supine position) - can reduce the risk of hypotension. When a patient lies on their side after receiving spinal anesthesia with a heavy (hyperbaric) local anesthetic, the medication tends to stay concentrated on the lower (operative) side, resulting in a more limited nerve block. This may help preserve blood pressure stability.
We will enroll 70 patients aged 65 years or older with high anesthetic risk (ASA physical status III or IV) scheduled for unilateral lower extremity orthopedic surgery under spinal anesthesia. Patients will be randomly assigned to two groups: one group will be kept in the lateral decubitus position (operative side down) for 15 minutes before being turned supine, and the other group will be turned supine immediately after spinal anesthesia. Blood pressure, heart rate, and oxygen saturation will be monitored continuously. The primary outcome is the incidence of hypotension during the first 15 minutes after spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator assessing sensory block levels and recording hemodynamic parameters was blinded to group allocation. Blinding of participants and care providers was not possible due to the nature of the positional intervention.
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
- •Age 65 years or older
- •ASA physical status classification III or IV
- •Scheduled for unilateral lower extremity orthopedic surgery (hip fracture, femur fracture, knee arthroplasty, tibia-fibula fracture, or similar procedures)
- •Eligible for spinal anesthesia
- •Written informed consent obtained
排除标准
- •Contraindications to spinal anesthesia (coagulopathy, recent anticoagulant or antiplatelet use without adequate washout period, local infection at injection site)
- •Severe neurological disease or pre-existing motor or sensory deficit
- •Significant spinal deformity (severe scoliosis, kyphosis) or history of previous spinal surgery
- •Known allergy to local anesthetics
- •Decompensated heart failure (ejection fraction below 30%)
- •Uncontrolled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
- •Emergency surgery
- •Severe hypovolemia or active bleeding
- •Advanced dementia or inability to communicate
- •Body mass index above 40 kg/m²
- •Refusal to participate
研究组 & 干预措施
Group L: Lateral Decubitus Position
After spinal anesthesia with 12 mg 0.5% hyperbaric bupivacaine in the sitting position, patients are immediately placed in the lateral decubitus position with the operative side down and maintained for 15 minutes, then turned supine.
干预措施: Lateral Decubitus Positioning (Other)
Group S: Immediate Supine Position
After spinal anesthesia with 12 mg 0.5% hyperbaric bupivacaine in the sitting position, patients are immediately turned to the supine position and maintained throughout the procedure.
干预措施: Immediate Supine Positioning (Other)
结局指标
主要结局
Incidence of Hypotension
时间窗: From spinal anesthesia to 15 minutes after administration
Hypotension defined as a decrease of 20% or more from baseline mean arterial pressure (MAP) or MAP below 65 mmHg, occurring at any time point between 1 and 15 minutes after spinal anesthesia.
次要结局
- Incidence of Bradycardia(From spinal anesthesia to 30 minutes after administration)
- Ephedrine Requirement(From spinal anesthesia to 30 minutes after administration)
- Atropine Requirement(From spinal anesthesia to 30 minutes after administration)
- Maximum Sensory Block Level(From spinal anesthesia to 30 minutes after administration)
- Incidence of Unilateral Sensory Block(15 and 30 minutes after spinal anesthesia administration)