Effect of Intraoperative Use of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients Undergoing Non-cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Postoperative mortality rate
研究概览
简要总结
China's aging population is causing an increase in the number of senior persons undergoing surgery. More and more clinicians are paying attention to the postoperative survival and mental health of elderly surgical patients.
Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. DEX has the potential to prevent and treat postoperative anxiety and depression in elderly patients undergoing non-cardiac surgery.
Further exploration of evidence for evidence-based medicine is needed. Based on the above research background, this hypothesis is proposed: in elderly patients undergoing noncardiac surgery, intraoperative DEX is associated with a reduction in short-term postoperative mental disorders and a reduction in long-term postoperative mortality.
详细描述
Studies have suggested that continuous infusion of low-dose DEX during the night after surgery can significantly reduce the incidence of delirium, alleviate pain, and improve subjective sleep quality.
However, it is currently unclear whether choosing DEX during anesthesia has any impact on mortality and mental disorders in older patients undergoing non-cardiac surgery.
Therefore, we utilized prospective research data from 7 centers in China to explore the relationship between intraoperative use of DEX and postoperative 12-month mortality and mental disorders. Propensity score-matching (PSM) and Inverse probability of treatment weighting (IPTW) were conducted, and subgroup analyses were also applied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years old, regardless of gender
- •Patients undergoing general anaesthesia (combined sedation or intravenous general anaesthesia)
- •ASA level 1-3
- •Patients undergoing elective non-cardiac surgery, non-neurosurgery
排除标准
- •More than 20% missing data for covariates;
- •Postoperative admission to the intensive care unit (ICU) or death during follow-up;
- •Preoperative history of severe sleep disorder and taking related medication;
- •Have a history of severe anxiety or depression prior to surgery and taking relevant medication;
- •Severe hearing, speech and cognitive impairments that preclude access to follow-up visits
研究组 & 干预措施
the DEX group
used DEX (safe use range: 0.2~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative mortality rate
时间窗: up to 12 month
the 12-month all-cause mortality
次要结局
- The incidence of postoperative delirium(During hospitalization (up to 1 month))
- The incidence of postoperative anxiety(Anxiety within 7 days of surgery)
- Postoperative sleep disorders(within 6 months after surgery)
- The incidence of postoperative depression(Depression within 7 days of surgery)
- Surgical related complications(within 12 months after surgery)
- Postoperative quality of life evaluation(within 12 months after surgery)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital