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Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery

2019年6月20日 更新者:Dong-Xin Wang、Peking University First Hospital

Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a Randomized Controlled Trial

Delirium is a frequent postoperative complication. Its occurrence is associated with worse long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose dexmedetomidine infusion during the early postoperative period decreased the incidence of delirium in elderly patients after surgery. The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.

研究概览

详细说明

Delirium is a frequent postoperative complication; a systematic review revealed that postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases with age. The occurrence of delirium is associated with worse long-term outcomes including worse functional recovery, decline in cognitive function, and increased mortality rate. Surgical stress, pain, and sleep disturbances are important factors leading to postoperative delirium in the elderly.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia.

In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo [normal saline] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% [79/350] with placebo vs. 9.1% [32/350] with dexmedetomidine; odds ratio 0.35, 95% confidence interval 0.22 to 0.54; p < 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population.

The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.

研究类型

介入性

注册 (实际的)

700

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beijing、中国、100034
        • Peking University First Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 至 90年 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

Patients were included if they met all of the following criteria:

  • Age of 65 years or older;
  • Underwent elective noncardiac surgery under general anesthesia;
  • Admitted to ICU after surgery.

Exclusion Criteria:

Patients were excluded if they met any of the following criteria:

  • Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
  • Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
  • Brain injury or neurosurgery;
  • Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or greater atrioventricular block without pacemaker;
  • Serious hepatic dysfunction (Child-Pugh class C);
  • Serious renal dysfunction (undergoing dialysis before surgery); or
  • Unlikely to survive for more than 24 hours.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:右美托咪定组
对于未插管的患者,右美托咪定的输注速度为每小时 0.1 微克/千克,从手术当天的研究招募到手术后第一天的上午 8:00。 对于插管和机械通气的患者,在进入重症监护病房后里士满躁动镇静量表为-2或更高后开始右美托咪定输注,直至术后第一天上午8:00。
小剂量右美托咪定输注
其他名称:
  • 盐酸右美托咪定
安慰剂比较:安慰剂组
生理盐水以与安慰剂组相同的速度输注相同的持续时间。
生理盐水输液
其他名称:
  • 生理盐水
  • 0.9%氯化钠

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Duration of 5-year survival after surgery
大体时间:From the day of surgery until the end of the 5th year after surgery
Duration of 5-year survival after surgery
From the day of surgery until the end of the 5th year after surgery

次要结果测量

结果测量
措施说明
大体时间
Survival rates after surgery
大体时间:At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
Survival rates at different timepoints after surgery
At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
Cognitive function in 5-year survivors after surgery
大体时间:At the end of the 5th year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
At the end of the 5th year after surgery
Health related quality of life in 5-year survivors after surgery
大体时间:At the end of the 5th year after surgery
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
At the end of the 5th year after surgery

其他结果措施

结果测量
措施说明
大体时间
Survival rates in the subgroup of patients after cancer or non-cancer surgery
大体时间:At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery
Survival rates at different time-points in the subgroup of patients after cancer or non-cancer surgery
At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery
Duration of survival in the subgroup of patients after cancer or non-cancer surgery
大体时间:From the day of surgery until the end of the 5th year after surgery
Duration of survival in the subgroup of patients after cancer or non-cancer surgery
From the day of surgery until the end of the 5th year after surgery
Cognitive function in the subgroup of 5-year survivors after cancer or non-cancer surgery
大体时间:At the end of the 5th year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
At the end of the 5th year after surgery
Health related quality of life in the subgroup of 5-year survivors after cancer or non-cancer surgery
大体时间:At the end of the 5th year after surgery
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
At the end of the 5th year after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年6月1日

初级完成 (实际的)

2019年1月8日

研究完成 (实际的)

2019年4月1日

研究注册日期

首次提交

2018年2月12日

首先提交符合 QC 标准的

2018年2月12日

首次发布 (实际的)

2018年2月19日

研究记录更新

最后更新发布 (实际的)

2019年6月21日

上次提交的符合 QC 标准的更新

2019年6月20日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Data will be provided on request.

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