Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications

Laparotomy Clinical Trial

— CIPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03216759
• Other study ID #: CIPS
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2017
• Last updated: July 11, 2017
• Start date: August 2017
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Cai Li, M.D
• Phone: +86-18602017796
• Email: licaisysu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 182
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 70 years;

• Elective abdominal surgery under general anesthesia, operation time > 2h;

• ASA ? ~ ?;

• 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.

Related Conditions & MeSH terms

• Intestinal Complications
• Laparotomy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

References & Publications (2)

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 corona — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Postoperative heart and respiratory complications within one week	Postoperative heart and respiratory complications within one week	12 hours to one week after surgery