Assessment of the effect of gabapentin as an analgesic replacement on the Kidney function following Laparoscopic sleeve gastrectomy for Morbid Obese Patients by measuring two biomarkers: NGAL (Neutrophil gelatinase-associated lipocalin)and DKK3 (Dickkopf-3)
Obesity should be viewed as the number one preventable risk factor for kidney disease because obesity mediates the majority of diabetes and hypertension, the 2 major causes of end-stage kidney disease (ESKD). Morbidly obese adults have a 6-fold higher risk of diabetes compared with their lean peers. Laparoscopic sleeve gastrectomy (LSG) has been approved since 2010, by both the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS) as an operation for the treatment of obesity and other obesity-related diseases. Acute kidney injury (AKI) is one of the most common postoperative complications. It is a serious morbidity occurring during hospitalizations, and it is associated with prolonged hospital stay, high risk of in-hospital mortality, increased hospital costs, and decreased survival for up to 15 years after surgery. In addition, AKI increases the risk of incident and progressive chronic kidney disease and is associated with reduced long-term survival. Non-steroidal anti-inflammatory drugs (NSAIDs) represent one of the most common classes of medications used postoperatively. It is estimated that 1-5% of NSAIDs users may develop renal adverse effects, both AKI and CKD. Gabapentin, an anticonvulsant widely used for the treatment of various neuropathic pain syndromes, has recently been investigated as an analgesic agent in the perioperative setting. Although it is not an analgesic itself, early experience suggests this medication can improve pain and reduce opioid requirements. A new animal study shows that gabapentin demonstrated reno-protective properties against either acute or chronic kidney injury, primarily attributed to its antioxidant properties. Further clinical studies are required to validate and standardize therapeutic doses of gabapentin under investigation in patients susceptible or at risk of developing kidney dysfunction. In this study, Neutrophil gelatinase-associated lipocalin (NGAL) and Dickkopf-3 (DKK3) will be biomarkers to assess kidney function. NGAL appears to be a promising marker for early detection of AKI and is likely to be adapted for wide-scale clinical use in patient management as a point-of-care test. Measurement of DKK3 in urine represents a novel tool for the identification of patients at high risk for AKI regardless of the cause of kidney injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Gabapentin is a drug that is commonly used to treat neuropathic pain, epilepsy, and other neurological disorders. According to some studies, gabapentin may affect the Wnt signaling pathway. In this study Gabapentin will be given by a dose of 1200 mg 1 hour before a laparoscopic sleeve gastrectomy(LSG) to decrease postoperative pain and opioid consumption. As acute kidney injury is a common condition following LSG , and as gabapentin has a positive effect on decreasing AKI induced in animal studies, we assess the effect of gabapentin on the AKI status following LSG
A placebo is a sham medical treatment that appears to be a real medical intervention but has no therapeutic effect. It is often used in clinical trials to compare the effects of a new treatment to those of a placebo. Common examples of placebos include inert tablets (like sugar pills), inert injections (like saline), and even sham surgery or other procedures. Placebos are typically made of inactive substances such as starch or sugar and are designed to be indistinguishable from the actual treatment
Tanta University
Tanta, Egypt
Level of Neutrophil gelatinase-associated lipocalin (NGAL)
Neutrophil gelatinase-associated lipocalin in Serum using ELISA Kits
Time frame: up to 6 months postoperative
Level of Dickkopf-3 (DKK3)
Dickkopf-3 in both serum and urine using ELISA kits
Time frame: up to 6 months postoperative
Kidney function test
Blood urea nitrogen
Time frame: up to 6 months postoperative
level of Serum creatinine
Time frame: up to 6 months postoperative
lipid profile (Triglycerides, LDL, HDL)
Time frame: up to 6 months postoperative
Concentration of calcium in serum
Time frame: up to 6 months postoperative
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