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Completed

NCT Number: NCT06254183

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

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

gabapentin 1200 mg

Drug

A single oral dose of 1200 mg gabapentin administered approximately 1 hour prior to induction of anesthesia for laparoscopic sleeve gastrectomy.

Other names: Neurontin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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