Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications in Patients Undergoing Laparotomy With General Anesthesia

Conditions
-----------------
Intestinal Complications, Laparotomy

Intervention / Treatment
-----------------
* Procedure: Ischemic preconditioning
* Drug: Dexmedetomidine
* Procedure: Patient-controlled epidural analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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. | |
| Experimental: intervention<br>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. | Procedure: Ischemic preconditioning<br>* After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.<br>Drug: Dexmedetomidine<br>* At the beginning of anesthesia induction, 3 ug/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.<br>Procedure: Patient-controlled epidural analgesia<br>* Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.The first volume of morphine 2mg + 0.2% ropivacaine + 0.9% saline 6ml, maintenance dose of morphine 18mg + 0.1% ropivacaine + 0.9% saline total 150ml. PCEA work with a continuous background dose of 2 ml/h with a single dose of 2ml/time, load 2ml, locking time 15min.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of digestive system complications after operation | The incidence of digestive system complications within one week after surgery | 12 hours to one week after surgery | 
| The concentration of intestinal fatty acid-binding protein (I-FABP) | The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation | 12 h after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative heart and respiratory complications within one week | Postoperative heart and respiratory complications within one week | 12 hours to one week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comprehensive intestinal protection strategy, Intestinal complications, laparotomy