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Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03216759
Acronym
CIPS
Enrollment
182
Registered
2017-07-13
Start date
2017-08-31
Completion date
2018-12-31
Last updated
2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Complications, Laparotomy

Keywords

Comprehensive intestinal protection strategy, Intestinal complications, laparotomy

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.

Interventions

PROCEDUREIschemic preconditioning

After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.

DRUGDexmedetomidine

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.

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.

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of digestive system complications after operation12 hours to one week after surgeryThe incidence of digestive system complications within one week after surgery
The concentration of intestinal fatty acid-binding protein (I-FABP)12 h after operationThe concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation

Secondary

MeasureTime frameDescription
Postoperative heart and respiratory complications within one week12 hours to one week after surgeryPostoperative heart and respiratory complications within one week

Contacts

Primary ContactCai Li, M.D
licaisysu@163.com+86-18602017796

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026