Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications (CIPS)

July 11, 2017 updated by: Kexuan Liu, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.
EXPERIMENTAL: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of digestive system complications after operation
Time Frame: 12 hours to one week after surgery
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)
Time Frame: 12 h after operation
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
Time Frame: 12 hours to one week after surgery
Postoperative heart and respiratory complications within one week
12 hours to one week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2017

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (ACTUAL)

July 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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