Clinical Study Evaluating the Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy (LSG) for Morbid Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Urinary Dickkopf-3 (DKK3) concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor was blinded to treatment allocation in the two randomized surgical groups. Participants and care providers were not blinded because no placebo was used.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Laparoscopic Sleeve Gastrectomy (Procedure)
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.
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.
干预措施: Laparoscopic Sleeve Gastrectomy (Procedure)
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.
干预措施: gabapentin 1200 mg (Drug)
结局指标
主要结局
Urinary Dickkopf-3 (DKK3) concentration
时间窗: 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
Change in renal function markers (serum creatinine and BUN) from baseline
时间窗: Baseline,24 hours postoperatively and 6 months after surgery
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.
次要结局
- Serum Dickkopf-3 concentration(Baseline, 24 hours postoperatively, and 6 months after surgery)
- Serum neutrophil gelatinase-associated lipocalin (NGAL) concentration(Baseline, 24 hours postoperatively, and 6 months after surgery)
- Serum creatinine (SCr) concentration(Baseline and 24 hours postoperatively)
- Blood urea nitrogen (BUN) concentration(Baseline and 24 hours postoperatively)
- Estimated glomerular filtration rate (eGFR)(Baseline and 24 hours postoperatively)
- 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)
研究者
Kholoud Salah Ibrahim Amin
Principle Investigator
Delta University for Science and Technology