Spinal Versus General Anaesthesia for Hip and Knee Arthroplasty. The Randomised, Clinical, Multicentre SPIGA Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- Hospital-free days within 30 days
研究概览
简要总结
Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.
详细描述
Effective and safe anaesthesia is fundamental to perioperative care. Hip and knee arthroplasty are among the most frequently performed surgical procedures worldwide and are typically performed under either spinal or general anaesthesia. However, high-quality comparative evidence regarding the benefits and harms of these anaesthetic techniques remains limited and inconclusive.
Both techniques are associated with short- and long-term risks, including postoperative nausea and vomiting, hypotension, nerve injury, acute kidney injury, and respiratory and cardiovascular complications. In addition, they may differentially modulate the surgical stress response, potentially influencing postoperative recovery and risk of complications.
Objective:
To compare the benefits and harms of spinal versus general anaesthesia in patients undergoing hip or knee replacement. We hypothesise that spinal anaesthesia results in better postoperative outcomes than general anaesthesia.
Intervention:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee
排除标准
- •Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee
- •Age ≥ 18 years
- •Unable to communicate in written and/or spoken Danish Contraindications against either spinal or general anaesthesia
研究组 & 干预措施
General Anaesthesia
干预措施: General anaesthesia (Procedure)
Spinal Anaesthesia
干预措施: Spinal anaesthesia (Procedure)
结局指标
主要结局
Hospital-free days within 30 days
时间窗: Postoperative day 0-30
Defined as the number of days within the first 30 days following hip or knee arthroplasty surgery during which a participant is alive and not admitted to a hospital.
次要结局
- Major complications(Postoperative day 0-30)
- Quality of Recovery(24 hours postoperatively)
研究者
Ole Mathiesen
MD, PhD, Chair Professor
Zealand University Hospital