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

NCT06254183 | Completed Phase 4

• 2 other identifiers: Gabapentin use in LSGTP/RE/12/22M-0073
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Acute Kidney Injury; Obesity (BMI > 35)

Keywords

Gabapentin; Nephroprotection; Preoperative Medication; Obesity Surgery; AKI; Postoperative Complications; Bariatric Surgery; Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Change in renal function markers (serum creatinine and BUN) from baseline

  Serum creatinine (mg/dL) and blood urea nitrogen, BUN (mg/dL) measured preoperatively (baseline) and at 24 hours after laparoscopic sleeve gastrectomy; primary analysis is the change from baseline to 24 hours postoperatively.

  Baseline,24 hours postoperatively and 6 months after surgery

Secondary Outcomes (2)

• Level of NGAL

  Baseline, 24 hours postoperatively and 6 months after surgery

• Level of Dickkopf-3 (DKK3)

  Baseline,24 hours postoperatively and 6 months after surgery

Other Outcomes (3)

• Change in lipid profile from baseline

  Baseline and 6 months after surgery

• Serum calcium level

  Baseline, 24 hours postoperatively and 6 months

• Serum uric acid level

  Baseline,24 hours postoperatively and 6 months after surgery

Study Arms (3)

Gabapentin + LSG

EXPERIMENTAL

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.

Procedure: Laparoscopic Sleeve Gastrectomy; Drug: gabapentin 1200 mg

Control

NO INTERVENTION

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

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.

Procedure: Laparoscopic Sleeve Gastrectomy

Interventions

Laparoscopic Sleeve Gastrectomy PROCEDURE

Standard laparoscopic sleeve gastrectomy performed under general anesthesia according to institutional protocol, with gastric resection over a calibration bougie.

Also known as: Bariatric Surgery, LSG, Sleeve Gastrectomy

Gabapentin + LSG; LSG Only

gabapentin 1200 mg DRUG

A single oral dose of 1200 mg gabapentin administered 1 hour prior to induction of anesthesia for laparoscopic sleeve gastrectomy. The medication is given as two 600 mg tablets ((Unipharma Co.)

Also known as: Neurontin

Gabapentin + LSG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Related Publications (6)

• Kovesdy CP, Furth SL, Zoccali C; World Kidney Day Steering Committee. Obesity and kidney disease: hidden consequences of the epidemic. J Nephrol. 2017 Feb;30(1):1-10. doi: 10.1007/s40620-017-0377-y.

  PMID: 28214961 BACKGROUND

• Kovesdy CP, Furth SL, Zoccali C. Obesity and kidney disease: hidden consequences of the epidemic. Braz J Med Biol Res. 2017 Apr 13;50(5):e6075. doi: 10.1590/1414-431X20166075.

  PMID: 28423118 BACKGROUND

• Hassani V, Pazouki A, Nikoubakht N, Chaichian S, Sayarifard A, Shakib Khankandi A. The effect of gabapentin on reducing pain after laparoscopic gastric bypass surgery in patients with morbid obesity: a randomized clinical trial. Anesth Pain Med. 2015 Feb 1;5(1):e22372. doi: 10.5812/aapm.22372. eCollection 2015 Feb.

  PMID: 25789237 BACKGROUND

• Rupniewska-Ladyko A, Malec-Milewska M, Kraszewska E, Pirozynski M. Gabapentin before laparoscopic sleeve gastrectomy reduces postoperative oxycodone consumption in obese patients: a randomized double-blind placebo-controlled trial. Minerva Anestesiol. 2018 May;84(5):565-571. doi: 10.23736/S0375-9393.17.12194-2. Epub 2017 Nov 6.

  PMID: 29108405 BACKGROUND

• Zewinger S, Rauen T, Rudnicki M, Federico G, Wagner M, Triem S, Schunk SJ, Petrakis I, Schmit D, Wagenpfeil S, Heine GH, Mayer G, Floege J, Fliser D, Grone HJ, Speer T. Dickkopf-3 (DKK3) in Urine Identifies Patients with Short-Term Risk of eGFR Loss. J Am Soc Nephrol. 2018 Nov;29(11):2722-2733. doi: 10.1681/ASN.2018040405. Epub 2018 Oct 2.

  PMID: 30279273 BACKGROUND

• Kim CS, Oak CY, Kim HY, Kang YU, Choi JS, Bae EH, Ma SK, Kweon SS, Kim SW. Incidence, predictive factors, and clinical outcomes of acute kidney injury after gastric surgery for gastric cancer. PLoS One. 2013 Dec 9;8(12):e82289. doi: 10.1371/journal.pone.0082289. eCollection 2013.

  PMID: 24349249 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Obesity; Postoperative Complications

Interventions

Bariatric Surgery; Gabapentin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kholoud Salah Ibraahim Amin, Bsc.

  Delta university for Sciences and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Patients will be randomly allocated into three study groups. Group I (control group) will include 30 patients who will neither undergo laparoscopic sleeve gastrectomy (LSG) nor receive any pharmacological treatment or placebo. Group II (Operation only) will consist of 30 patients who will undergo LSG without receiving any preoperative medication. Group III (Operation+ treatment) will comprise 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. Blood and urine samples will be collected in follow-up, 6 months postoperatively.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 12, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 30, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

EG (1)