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

August 14, 2026 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

This study evaluated the effect of a single preoperative dose of gabapentin on renal stress and kidney function following laparoscopic sleeve gastrectomy in adults with severe obesity. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to surgery without preoperative gabapentin or surgery after a single 1200-mg oral dose of gabapentin. An additional 30 non-operative participants with severe obesity served as a non-randomized external reference cohort. Renal assessment included conventional kidney function markers and biomarkers, including Dickkopf-3 (DKK3) and neutrophil gelatinase-associated lipocalin (NGAL). The prespecified primary endpoint was urinary DKK3 concentration at 24 hours postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is an important risk factor for kidney disease because it is strongly associated with diabetes and hypertension, two major causes of end-stage kidney disease (ESKD). Adults with severe obesity are at increased risk of diabetes compared with lean individuals. Laparoscopic sleeve gastrectomy (LSG) is an established surgical treatment for obesity and obesity-related diseases.

Acute kidney injury (AKI) is an important postoperative complication associated with prolonged hospital stay, increased hospital costs, higher mortality, and an increased risk of subsequent chronic kidney disease. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used postoperatively and may contribute to renal adverse effects in susceptible patients.

Gabapentin is an anticonvulsant widely used for neuropathic pain and has also been investigated in the perioperative setting for reducing postoperative pain and opioid requirements. Experimental studies have suggested that gabapentin may influence pathways related to oxidative stress and renal injury; however, its effects on perioperative renal stress in clinical settings remain uncertain.

Neutrophil gelatinase-associated lipocalin (NGAL) and Dickkopf-3 (DKK3) were evaluated as biomarkers of renal stress and kidney injury. NGAL has been investigated as an early biomarker of AKI, whereas urinary DKK3 has been proposed as a marker of renal tubular stress and risk of kidney injury.

The study included 90 participants. Sixty participants undergoing LSG were randomized in a 1:1 ratio to LSG without preoperative gabapentin or LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. An additional 30 participants with severe obesity who did not undergo surgery served as a non-randomized external reference cohort. Blood and urine samples were obtained at baseline, 24 hours postoperatively, and 6 months after surgery in the randomized surgical groups, whereas the external reference cohort underwent a single assessment at enrollment.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Mansoura University hospitals
      • Tanta, Egypt
        • Tanta University Hospitals

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

No

Description

Inclusion Criteria:

  • Age: 18-65 years old.
  • Participants with severe obesity (BMI ≥40 kg/m², without comorbidities or BMI ≥35 kg/m², in the presence of obesity-related comorbidities).
  • Preserved kidney function at baseline.
  • For the randomized surgical cohort (Groups II and III), participants with severe obesity scheduled to undergo laparoscopic sleeve gastrectomy.
  • For the non-randomized external reference cohort (Group I), participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy during the study period or receive the study intervention.
  • Both sexes.

Exclusion Criteria:

  • Advanced cancer receiving active treatment.
  • End-stage renal, hepatic, or cardiopulmonary disease.
  • Untreated schizophrenia or cognitive impairment.
  • Use of psychiatric medications, as specified in the study protocol.
  • Active substance abuse.
  • Chronic use of gabapentin or known hypersensitivity to gabapentin.
  • Pregnancy or breastfeeding.
  • Use of medications that could interfere with the assessed study parameter

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group III (Gabapentin + LSG)
Thirty participants underwent laparoscopic sleeve gastrectomy after receiving a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. Blood and urine samples were collected at baseline before administration of gabapentin, 24 hours postoperatively, and at 6 months after surgery.
Procedure: Laparoscopic Sleeve Gastrectomy
Standard laparoscopic sleeve gastrectomy performed under general anesthesia according to institutional protocol, with gastric resection over a calibration bougie.
Other Names:
  • Bariatric Surgery
  • LSG
  • Sleeve Gastrectomy
Drug: gabapentin 1200 mg
A single oral dose of 1200 mg gabapentin administered approximately 1 hour prior to induction of anesthesia for laparoscopic sleeve gastrectomy.
Other Names:
  • Neurontin
No Intervention: Group I (External reference cohort)
Thirty participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy and did not receive the study intervention. Blood and urine samples were collected once at enrollment.
Active Comparator: Group II (LSG Only)
Thirty participants underwent laparoscopic sleeve gastrectomy without receiving preoperative gabapentin or placebo. Blood and urine samples were collected at baseline before surgery, 24 hours postoperatively, and at 6 months after surgery.
Procedure: Laparoscopic Sleeve Gastrectomy
Standard laparoscopic sleeve gastrectomy performed under general anesthesia according to institutional protocol, with gastric resection over a calibration bougie.
Other Names:
  • Bariatric Surgery
  • LSG
  • Sleeve Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Dickkopf-3 (DKK3) concentration
Time Frame: Baseline, 24 hours postoperatively, and 6 months after surgery
Urinary DKK3 was measured by ELISA at baseline, 24 hours postoperatively, and 6 months after surgery. The prespecified primary endpoint was the 24-hour postoperative urinary DKK3 concentration, with the primary comparison performed between the two randomized surgical groups (Group II and Group III) after adjustment for baseline urinary DKK3
Baseline, 24 hours postoperatively, and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Dickkopf-3 concentration
Time Frame: Baseline, 24 hours postoperatively, and 6 months after surgery
Serum DKK3 concentration was measured by ELISA as a biomarker of renal stress.
Baseline, 24 hours postoperatively, and 6 months after surgery
Serum neutrophil gelatinase-associated lipocalin (NGAL) concentration
Time Frame: Baseline, 24 hours postoperatively, and 6 months after surgery
Serum NGAL concentration was measured by ELISA as a biomarker of acute kidney injury.
Baseline, 24 hours postoperatively, and 6 months after surgery
Serum creatinine (SCr) concentration
Time Frame: Baseline and 24 hours postoperatively
Serum creatinine (SCr) was measured to assess kidney function in the randomized surgical groups.
Baseline and 24 hours postoperatively
Blood urea nitrogen (BUN) concentration
Time Frame: Baseline and 24 hours postoperatively
Blood urea nitrogen (BUN) was measured as a conventional marker of kidney function in the randomized surgical groups.
Baseline and 24 hours postoperatively
Estimated glomerular filtration rate (eGFR)
Time Frame: Baseline and 24 hours postoperatively
Estimated glomerular filtration rate (eGFR) was calculated from serum creatinine using the 2021 CKD-EPI creatinine equation to assess kidney function.
Baseline and 24 hours postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lipid profile from baseline
Time Frame: Baseline and 6 months after surgery
Total cholesterol, LDL-C, HDL-C, and triglycerides measured preoperatively (baseline) and at 6 months postoperatively; change from baseline to 6 months.
Baseline and 6 months after surgery
Serum calcium level
Time Frame: Baseline and 24 hours postoperatively
Serum calcium (mg/dL) measured preoperatively (baseline) and at 24 hours after surgery to assess concomitant electrolyte/metabolic factors that may be associated with postoperative renal dysfunction.
Baseline and 24 hours postoperatively
Serum uric acid level
Time Frame: Baseline and 24 hours postoperatively
Serum uric acid (mg/dL) measured preoperatively (baseline) and at 24 hours after surgery to assess concomitant metabolic factors that may be associated with postoperative renal dysfunction.
Baseline and 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Principal Investigator: Kholoud Salah Ibraahim Amin, Bsc., Delta university for Sciences and Technology

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 (Actual)

December 1, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

November 30, 2025

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)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gabapentin use in LSG
  • TP/RE/12/22M-0073 (Other Identifier: National Research Ethics Committee of Tanta University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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