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临床试验/NCT06835010
NCT06835010已完成不适用

Contradictory Effect of Sevoflurane and Dexmedetomidine on Kidney Function After Non-Cardiac Surgical Procedures Possibly Through Immunomodulation and Adjustment of Redox Milieu

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月20日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Percentage Difference in Serum Creatinine levels After Dexmedetomidine Administration in Total Knee Replacement surgery under sevoflurane anesthesia.

研究概览

简要总结

Postoperative acute kidney injury (PO-AKI) is a significant complication, especially after complex surgeries. The choice of anesthetic may influence PO-AKI risk. While sevoflurane (SEVO) has been associated with potential renal risks, dexmedetomidine (DXM) has demonstrated renoprotective effects in various surgical settings. These protective effects may be linked to DXM's immunomodulatory properties and influence on the redox balance. Given the common use of SEVO in major non-cardiac surgery and the potential for renal vulnerability, particularly in the elderly, this study hypothesizes that perioperative DXM infusion in patients undergoing major non-cardiac surgery with SEVO anesthesia will reduce the incidence and severity of PO-AKI, especially in those with pre-existing or borderline renal dysfunction.

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
Double (Participant, Care Provider)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who were assigned for TKR surgery;
  • Patients with preoperative serum creatinine (SCr) levels of <1.1 mg/ml;
  • Patients with controlled medical conditions;
  • Patients free of exclusion criteria were enrolled in the study.

排除标准

  • Male patients were excluded to guard against the impact of senile prostatic hypertrophy on kidney functions;
  • Patients who had preoperative SCr of >1.1 mg/dl;
  • Presence of any urological disorders, urological stone diseases;
  • Patients with autoimmune diseases, medical disorders requiring maintenance on immunosuppressant therapy;
  • Patients with cancer anywhere in the body were excluded.

研究组 & 干预措施

SEVO Group

Active Comparator

干预措施: Sevoflurane inhalant product (Drug)

DXM Group

Active Comparator

干预措施: Dexmedetomidine (Drug)

DXM Group

Active Comparator

干预措施: Sevoflurane inhalant product (Drug)

结局指标

主要结局

Percentage Difference in Serum Creatinine levels After Dexmedetomidine Administration in Total Knee Replacement surgery under sevoflurane anesthesia.

时间窗: 5 months

The study assesses the mean percentage difference of serum creatinine levels in patients who was undergoing total knee replacement under sevoflurane anesthesia with Dexmedetomidine infusion (using standard laboratory assays).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Lotfy

Assistant Professor

Tanta University

研究点 (1)

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