Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Onset time of the motor block
研究概览
简要总结
This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.
详细描述
The increasing demand for day-case surgery has led to a growing interest in developing strategies to provide patients with a more convenient, cost-effective, and less invasive alternative to traditional inpatient procedures.
Spinal anesthesia, in particular, is a widely used technique in day-case surgery due to its ability to provide excellent analgesia with minimal side effects.
Intravenous lipid emulsion therapy is commonly used to treat local anesthetic systemic toxicity (LAST) and has demonstrated some efficacy in treating other drug toxicities, particularly cardiotoxicity from lipophilic drugs.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Scheduled for day-case surgery under spinal anesthesia.
- •Time of surgery less than 90 min.
排除标准
- •Patients with contraindications for outpatient surgery or spinal anesthesia.
- •Local anaesthetic (LA) allergy.
- •Those receiving anticoagulant therapy.
- •Emergency cases.
- •Pregnant cases.
研究组 & 干预措施
Group S
Patients (>70kg will receive 100 ml, <70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group.
干预措施: Lipid emulsion (Other)
Group C
Patients will not receive intravenous lipid emulsion as a control group.
结局指标
主要结局
Onset time of the motor block
时间窗: Intraoperatively
The onset time of the motor block using the modified Bromage scale will be assessed. The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).
次要结局
- Duration of motor block(Intraoperatively)
- Time till home readiness(24 hours postoperatively)
- Time to the 1st rescue analgesia(24 hours postoperatively)
- Total tramadol consumption(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
- Time from the end of surgery till movement(24 hours postoperatively)
研究者
Mahmoud Sharara, MD
Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Benha University, Egypt.
Benha University