Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications
NCT ID: NCT03216759
Last Updated: 2017-07-13
Study Results
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Basic Information
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UNKNOWN
NA
182 participants
INTERVENTIONAL
2017-08-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
No interventions assigned to this group
intervention
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Elective abdominal surgery under general anesthesia, operation time \> 2h;
* ASA Ⅰ \~ Ⅲ;
* Patient informed and consent to accept the test.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Kexuan Liu
Director, Head of Anesthesiology, Principal Investigator, Clinical Professor
Principal Investigators
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Ke-Xuan Liu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, the Southern Medical University
Central Contacts
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References
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Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
Other Identifiers
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CIPS
Identifier Type: -
Identifier Source: org_study_id
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