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

NCT06254183

CompletedPhase 4

Sponsor: Tanta University

Conditions: Acute Kidney Injury, Obesity

Interventions: Laparoscopic Sleeve Gastrectomy, gabapentin 1200 mg

Countries: Egypt

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (2)
  • Al Mansurah, Egypt
  • Tanta, Egypt