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临床试验/NCT05247177
NCT05247177已完成不适用

Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Multimodal general anesthesia

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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