Dosing of Carcinogenic Complexes Such as Urinary O-toluidine and Hemoglobin Adducts From O-toluidine in Blood After Intrathecal Administration of 50 mg Hyperbaric Prilocaine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hemoglobin adducts from o-toluidine in blood
研究概览
简要总结
The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine, a human carcinogen.
Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : > 18 years and < 80years
- •American Society of Anesthesiology (ASA) score : I-II
- •Height between 160cm and 180cm
排除标准
- •Cardiac Disease (Aortic stenosis, heart failure...)
- •coagulation disorder (International Normalized Ratio (INR) > 1.3; platelets <80 000/mm³)
- •Allergic to local anesthetics
结局指标
主要结局
Hemoglobin adducts from o-toluidine in blood
时间窗: Time 24 hours after intrathecal prilocaine injection
Hemoglobin adducts from o-toluidine in blood is measured at 24 hours after intrathecal prilocaine injection
Urinary o-toluidine
时间窗: Time 24 hours after intrathecal prilocaine injection
Urinary o-toluidine is measured at 24 hours after intrathecal prilocaine injection
次要结局
未报告次要终点