Continuous Dexmedetomidine Infusion Reduces Postoperative Cognitive Dysfunction and Postoperative Pain in Patients Undergoing Laparatomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Postoperative cognitive dysfunction (POCD)
研究概览
简要总结
Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >= 18 years old
- •Scheduled for laparatomy surgery
排除标准
- •history of allergies to anaesthetic drugs
- •impaired consciousness
- •neurocognitive disorder
- •psychiatric disorder
- •mental disorder
- •cerebrovascular disorders
- •sick sinus syndrome
- •hypoalbuminemia
- •massive bleeding
- •liver disease
- •kidney diseases.
研究组 & 干预措施
Patients with POCD
MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
干预措施: Dexmedetomidine (Drug)
Patients with POCD
MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
干预措施: Sevoflurane (Drug)
Patients without POCD
MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
干预措施: Dexmedetomidine (Drug)
Patients without POCD
MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Postoperative cognitive dysfunction (POCD)
时间窗: 30 days postoperative
Assessed by Mini-Mental State Examination (MMSE). Defined if there is a \>= 2 points decrease compared to baseline.
次要结局
- Intraoperative hemodynamics: mean arterial pressure (MAP)(During the course of intraoperative period.)
- Intraoperative hemodynamics: heart rate (HR)(During the course of intraoperative period.)
- Postoperative pain(24 hours postoperative)
研究者
Christopher Ryalino, MD
Assistant Professor
Udayana University