Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications in Patients Undergoing Laparotomy With General Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 182
- 主要终点
- The incidence of digestive system complications after operation
研究概览
简要总结
To investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia.
详细描述
Perioperative intestinal injury is one of the common tissues and organs injury in surgical practice. However, there is a lack of effective means of prevention and treatment.The investigators previously found that ischemic preconditioning, IPC, and dexmedetomidine has protective effects on intestinal mucosal injury.
However, the combined effect of various factors has not been clinically validated. To explore the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia,the investigators select the patients undergoing open surgery under general anesthesia as the study subjects and the concentration of intestinal fatty acid binding protein (I-FABP) as well as the incidence of digestive system complications in one week after operation are the main observation indexes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years;
- •Elective abdominal surgery under general anesthesia, operation time > 2h;
- •ASA Ⅰ ~ Ⅲ;
- •Patient informed and consent to accept the test.
排除标准
- •persons under the age of 18 or over 70 years old;
- •pregnant or lactating women;
- •combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;
- •preoperative Hb <7g / l;
- •oral sulfa drugs or nicorandil antihypertensive drugs;
- •lower extremity amputees;
- •with peripheral vascular disease;
- •patients with mental illness or severe neurosis;
- •can not express the subjective symptoms;
- •nearly 3 months to participate in other drug clinical trials;
- •within 3 months of receiving other surgical treatment.
研究组 & 干预措施
intervention
- After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning.
- At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure.
- Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.
干预措施: Ischemic preconditioning (Procedure)
intervention
- After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning.
- At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure.
- Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.
干预措施: Dexmedetomidine (Drug)
intervention
- After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning.
- At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure.
- Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.
干预措施: Patient-controlled epidural analgesia (Procedure)
结局指标
主要结局
The incidence of digestive system complications after operation
时间窗: 12 hours to one week after surgery
The incidence of digestive system complications within one week after surgery
The concentration of intestinal fatty acid-binding protein (I-FABP)
时间窗: 12 h after operation
The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation
次要结局
- Postoperative heart and respiratory complications within one week(12 hours to one week after surgery)
研究者
Kexuan Liu
Director, Head of Anesthesiology, Principal Investigator, Clinical Professor
Nanfang Hospital, Southern Medical University