CIPS: Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: control group 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. |
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| Experimental: 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. |
Procedure: Ischemic preconditioning
After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.
Drug: Dexmedetomidine
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.
Procedure: Patient-controlled epidural analgesia
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.
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Outcome Measures
Primary Outcome Measures
- The incidence of digestive system complications after operation [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) [12 h after operation]
The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation
Secondary Outcome Measures
- Postoperative heart and respiratory complications within one week [12 hours to one week after surgery]
Postoperative heart and respiratory complications within one week
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged between 18 and 70 years;
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Elective abdominal surgery under general anesthesia, operation time > 2h;
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ASA Ⅰ ~ Ⅲ;
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Patient informed and consent to accept the test.
Exclusion Criteria:
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persons under the age of 18 or over 70 years old;
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pregnant or lactating women;
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combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;
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preoperative Hb <7g / l;
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oral sulfa drugs or nicorandil antihypertensive drugs;
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lower extremity amputees;
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with peripheral vascular disease;
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patients with mental illness or severe neurosis;
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can not express the subjective symptoms;
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nearly 3 months to participate in other drug clinical trials;
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within 3 months of receiving other surgical treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
Investigators
- Principal Investigator: Ke-Xuan Liu, Ph.D, Nanfang Hospital, the Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- CIPS