Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications (CIPS)

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Laparotomy; Intestinal Complications

Treatments: Procedure: Patient-controlled epidural analgesia; Procedure: Ischemic preconditioning; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03216759

CIPS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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182 participants in 2 patient groups

control group

No Intervention group

Description:

Tourniquet would be tied to left upper limb of Patients who undergoing laparotomy for 30 minutes after the induction of anesthesia,but put no press on it. Other processes are consistent with conventional methods.

intervention

Experimental group

Description:

1. After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning. 2. 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. 3. Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.

Treatment:

Procedure: Ischemic preconditioning

Procedure: Patient-controlled epidural analgesia

Drug: Dexmedetomidine