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

April 14, 2024 updated by: Kholoud Salah Ibrahim Amin, Tanta University

Clinical Study Evaluating the Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy (LSG) for Morbid Obese Patients

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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

Other Names:
  • GABA
Placebo Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: up to 6 months postoperative
Neutrophil gelatinase-associated lipocalin in Serum using ELISA Kits
up to 6 months postoperative
Level of Dickkopf-3 (DKK3)
Time Frame: up to 6 months postoperative
Dickkopf-3 in both serum and urine using ELISA kits
up to 6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney function test
Time Frame: up to 6 months postoperative
Blood urea nitrogen
up to 6 months postoperative
level of Serum creatinine
Time Frame: up to 6 months postoperative
up to 6 months postoperative
lipid profile (Triglycerides, LDL, HDL)
Time Frame: up to 6 months postoperative
up to 6 months postoperative
Concentration of calcium in serum
Time Frame: up to 6 months postoperative
up to 6 months postoperative

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Study Director: Gamal A. El-Azab, Professor, Tanta University
  • Principal Investigator: Ahmed Mohammed Hassan Shata, Professor, Delta 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gabapentin use in LSG

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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