Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Quality of Recovery Score
研究概览
简要总结
To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.
详细描述
Multimodal general anesthesia has been proposed in recent years. By administration of multiple agents acting on a different component of the nociceptive pathways, the multimodal general anesthesia may elicit maximal anesthetic effects with minimal anesthetic dose. These may be beneficial to improve postoperative recovery and reduce adverse effects such as postoperative delirium and perioperative neurocognitive impairment. It is not uncommon that elder patients undergoing lumbar spine fusion surgery suffer from postoperative poor recovery, postoperative delirium as well as the postoperative neurocognitive disorder. Therefore, this study aims to explore the potential effects of multimodal general anesthesia, which comprised with electroencephalography density spectrum array guided co-administration of sevoflurane, ketamine and dexmedetomidine, on the postoperative recovery profiles for elder patients undergoing lumbar spine fusion surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Multimodal general anesthesia
General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern
干预措施: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia (Drug)
Conventional general anesthesia
General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60
干预措施: Conventional general anesthesia by administration of sevoflurane alone (Drug)
结局指标
主要结局
Postoperative Quality of Recovery Score
时间窗: Change from Baseline QoR-15 to 24 hour after surgery
Postoperative Quality of Recovery Score assessed by using the QoR-15 system
次要结局
- Postoperative delirium(3 days)
- Postoperative chronic pain(3 months)
