Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications

Not Applicable

• Conditions: Intestinal Complications; Laparotomy
• Interventions: Procedure: Ischemic preconditioning; Drug: Dexmedetomidine; Procedure: Patient-controlled epidural analgesia

• Registration Number: NCT03216759
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Last Update Submitted: 2017-07-11
• Study First Posted: 2017-07-13
• Last Update Posted: 2017-07-13
• Study Start: 2017-08
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Ischemic preconditioning	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.
intervention	Patient-controlled epidural analgesia	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.
intervention	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Postoperative heart and respiratory complications within one week	12 hours to one week after surgery	Postoperative heart and respiratory complications within one week