Impact of Intraoperative Goal-directed Blood Pressure Management and Dexmedetomidine on Outcomes of High-risk Patients After Major Abdominal Surgeries: a 2×2 Factorial Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 1
- 主要终点
- Incidence of organ injury and other complications within 30 days after surgery.
研究概览
简要总结
Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality. Whereas individualized intraoperative blood pressure management is likely to decrease the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine, a highly selective alpha2 adrenergic agonist, has been shown to provide organ protective effects. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on incidence of postoperative organ injury in high-risk patients undergoing major surgery.
详细描述
The number of patients undergoing surgeries is increasing worldwide. However, some patients develop complications or even die after surgery. Perioperative organ injury is the leading cause of the unfavorable outcomes.
Hypotension is not uncommon during major surgery and is highly responsible for the inadequate perfusion and organ injury. A recent study showed that individualized blood pressure management decreases the incidence of postoperative organ injury when compared with standard blood pressure management strategy.
Dexmedetomidine is a highly selective alpha2 adrenergic agonist. Previous studies showed that dexmedetomidine provides organ protection in various conditions. In a recent meta-analysis, perioperative dexmedetomidine reduceds the occurrence of postoperative delirium. However, whether it can reduce postoperative complications remains inconclusive.
This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on the incidence of postoperative organ injury in high-risk patients undergoing major abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
For dexmedetomidine infusion, all the participants, care providers, investigators, outcomes assessors are masked. For blood pressure management, care providers, namely anesthesiologists, are not masked.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years or older;
- •Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
- •With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).
排除标准
- •Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);
- •Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
- •Severe bradycardia (heart rate < 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
- •Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate <30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
- •Pregnant;
- •Receiving dexmedetomidine or norepinephrine infusion before surgery;
- •Do not provide written informed consent.
研究组 & 干预措施
Placebo+routine blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
干预措施: Placebo (Drug)
Placebo+routine blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
干预措施: Routine blood pressure management (Other)
Dexmedetomidine+routine blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine+routine blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.
干预措施: Routine blood pressure management (Other)
Placebo+goal-directed blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
干预措施: Placebo (Drug)
Placebo+goal-directed blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
干预措施: Goal-directed blood pressure management (Other)
Dexmedetomidine+goal-directed blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine+goal-directed blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
干预措施: Goal-directed blood pressure management (Other)
结局指标
主要结局
Incidence of organ injury and other complications within 30 days after surgery.
时间窗: Up to 30 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
次要结局
- Incidence of organ injury and other complications within 7 days after surgery.(Up to 7 days after surgery.)
- Disease-free survival after surgery.(Up to 3 years after surgery.)
- Length of stay in the intensive care unit after surgery.(Up to 30 days after surgery.)
- Length of stay in hospital after surgery.(Up to 30 days after surgery.)
- 30-day all-cause mortality.(Up to 30 days after surgery.)
- Overall survival after surgery.(Up to 3 years after surgery.)
- Quality of life of 3-year survivors: WHOQOL-BREF(At the end of 3 years after surgery.)
- Cognition function of 3-year survivors.(At the end of 3 years after surgery.)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital