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临床试验/NCT05940935
NCT05940935已完成不适用

The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?

Trakya University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Intraoperative Metabolic Acidosis

研究概览

简要总结

The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations

详细描述

Metabolic acidosis is a life-threatening complication in the perioperative, intraoperative and postoperative period. It can cause decreased cardiac output, electrolyte imbalance, surgical bleeding and neurological complications, even coma and death in surgical patients.

Topiramate and zonisamide are sulfonamide derivative compounds used in the treatment of epilepsy. It has been shown in studies that both drugs have a strong inhibition of carbonic anhydrase enzyme. Recent case reports suggest that both drugs may cause metabolic acidosis by lowering serum bicarbonate levels in some patients.

Aim in this study is to determine the relationship between preoperative, intraoperative and postoperative metabolic acidosis and to emphasize the importance of anesthesia management in patients who have undergone craniotomy and use antiepileptic drugs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
  • ASA I-III
  • Patients undergoing elective surgery

排除标准

  • Patients with a surgical procedure time of more than 5 hours
  • Patients who received more than 2 units of blood transfusion during the operation
  • Patients taking other drugs that can cause metabolic acidosis
  • Patients with diabetes mellitus, diabetes insipidus, hepatic or renal disease

结局指标

主要结局

Intraoperative Metabolic Acidosis

时间窗: during the operation

The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

Preoperative Metabolic Acidosis

时间窗: Baseline

The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

Postoperative Metabolic Acidosis

时间窗: Day 1

The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

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

Onur Kucuk

Department of anesthesiology and reanimation, Principal Investigator, Resident Doctor

Trakya University

研究点 (1)

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