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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-05-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Acute Kidney Injury Bariatric Surgery Candidate Gabapentin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group I: 30 patients who will represent the control group and will receive oral placebo tab 2 days prior to surgery and 1 hr before surgery.

Group II: 30 patients who will represent the treatment group and will receive a single oral dose of Gabapentin 1200 mg, 1 hr before surgery.

Blood and urine samples will be collected before the surgery, then 24 hrs postoperatively.

Blood and urine samples will be collected in follow-up, 6 months postoperatively

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Gabapentin

30 patients will represent the treatment group and will receive a single oral dose of Gabapentin 1200 mg 1 hr before the surgery.

Blood and urine samples will be collected before the surgery, then 24 hrs postoperatively.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

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

Placebo

30 patients will represent the treatment group and will receive a single oral dose of Placebo 1 hr before the surgery.

Blood and urine samples will be collected before the surgery, then 24 hrs postoperatively.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Gabapentin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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GABA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes