Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy(LSG)

Tanta University

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury; Obesity (BMI > 35)

Treatments: Procedure: Laparoscopic Sleeve Gastrectomy; Drug: gabapentin 1200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06254183

Gabapentin use in LSG

TP/RE/12/22M-0073 (Other Identifier)

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Morbid obese patients with normal kidney function, undergoing Laparoscopic sleeve gastrectomy surgery.
• Both sexes.
• Age ≥ 18 years

Exclusion criteria

• • Patients have advanced cancer on active treatment and end-stage renal, hepatic, and cardiopulmonary disease.

  • Patients with untreated schizophrenia, cognitive impairment and using psychiatric medications.
  • Patients with active substance abuse.
  • Patients on chronic dosage of Gabapentin or allergic to it.
  • Pregnant women or women on breastfeeding.
  • Patients on medications that could interfere with assessed parameters will be excluded.

The ethical approval of the study will be obtained from by Medical research Ethics Committee of Tanta and Mansoura Universities and all participants will give their written consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Gabapentin + LSG

Experimental group

Description:

30 patients who will undergo LSG after receiving a single oral dose of Gabapentin 1200 mg, 1 hour prior to surgery. Blood and urine samples will be collected Just before the surgery, then 24 hrs. postoperatively.

Treatment:

Drug: gabapentin 1200 mg

Procedure: Laparoscopic Sleeve Gastrectomy

Control

No Intervention group

Description:

30 patients who will neither undergo laparoscopic sleeve gastrectomy (LSG) nor receive any pharmacological treatment or placebo. Blood and urine samples will be collected just before the surgery, then 24 hrs postoperatively.

LSG Only

Active Comparator group

Description:

30 patients who will undergo LSG without receiving any preoperative medication. Blood and urine samples will be collected Just before the surgery, then 24 hrs. postoperatively.

Treatment:

Procedure: Laparoscopic Sleeve Gastrectomy