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临床试验/NCT01934049
NCT01934049Unknown4 期

The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
80
试验地点
1
主要终点
postoperative cognitive dysfunction(POCD)

研究概览

简要总结

Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization, which can cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in order to improve postoperative recovery and prevent and treating PD and POCD.

Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.

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
None

入排标准

年龄范围
75 Years 至 —(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

Dexmedetomidine

Active Comparator

Dexmedetomidine in dex group is administered as 1ug/kg by intravenous infusion 10 min and then 0.6 ug/kg until 30 minutes before the operation finishes.

干预措施: hip arthroplasty (Procedure)

Dexmedetomidine

Active Comparator

Dexmedetomidine in dex group is administered as 1ug/kg by intravenous infusion 10 min and then 0.6 ug/kg until 30 minutes before the operation finishes.

干预措施: Total Intravenous Anesthesia and Peripheral nerve blocks (Drug)

Saline

Placebo Comparator

Participants in con group receive placebo(saline) as the same dose at the same time as dex group.

干预措施: hip arthroplasty (Procedure)

Saline

Placebo Comparator

Participants in con group receive placebo(saline) as the same dose at the same time as dex group.

干预措施: Total Intravenous Anesthesia and Peripheral nerve blocks (Drug)

结局指标

主要结局

postoperative cognitive dysfunction(POCD)

时间窗: 7days

POCD is assessed by Montreal Cognitive Assessment(MoCA), which was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration,executive functions, memory, language,visuoconstructional skills, conceptual thinking,calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.

次要结局

  • Postoperative recovery(7days)
  • Postoperative Delirium(PD)(72 hours)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junle Liu

Principal Investigator

Chinese PLA General Hospital

研究点 (1)

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