Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery
Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a 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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing、中国、100034
- Peking University First Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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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。
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小剂量右美托咪定输注
其他名称:
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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。
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生理盐水输液
其他名称:
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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 |
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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
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Duration of 5-year survival after surgery
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From the day of surgery until the end of the 5th year after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Survival rates after surgery
大体时间:At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
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Survival rates at different timepoints after surgery
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At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
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Cognitive function in 5-year survivors after surgery
大体时间:At the end of the 5th year after surgery
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Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
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At the end of the 5th year after surgery
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Health related quality of life in 5-year survivors after surgery
大体时间:At the end of the 5th year after surgery
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Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
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At the end of the 5th year after surgery
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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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
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Survival rates at different time-points in the subgroup of patients after cancer or non-cancer surgery
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At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery
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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
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Duration of survival in the subgroup of patients after cancer or non-cancer surgery
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From the day of surgery until the end of the 5th year after surgery
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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
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Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
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At the end of the 5th year after surgery
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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
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Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
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At the end of the 5th year after surgery
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合作者和调查者
出版物和有用的链接
一般刊物
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- Liu C, Zhang Y, She S, Xu L, Ruan X. A randomised controlled trial of dexmedetomidine for suspension laryngoscopy. Anaesthesia. 2013 Jan;68(1):60-6. doi: 10.1111/j.1365-2044.2012.07331.x. Epub 2012 Oct 29.
- Gozalo-Marcilla M, Hopster K, Gasthuys F, Hatz L, Krajewski AE, Schauvliege S. Effects of a constant-rate infusion of dexmedetomidine on the minimal alveolar concentration of sevoflurane in ponies. Equine Vet J. 2013 Mar;45(2):204-8. doi: 10.1111/j.2042-3306.2012.00613.x. Epub 2012 Aug 1.
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Dex-5-2016
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
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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