Determination of Serum Paracetamol Concentration With an Electrochemical Measurement Tool From Blood and Saliva Samples in Patients Using Also Other Medication.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- No outcome for patients
研究概览
简要总结
Paracetamol intoxication is common, and concentration measurements are performed regularly. This research group is developing a fast bedside electrochemical analysis tool for paracetamol concentration measurement. This study will find out how this novel method performs in patients using other, confounding medication in detecting paracetamol concentration in capillary blood, venous plasma and saliva samples.
详细描述
Paracetamol concentration analysis is performed in 20 patients who will come to hospital for elective surgery. Inclusion criteria is a regular medication that continues over perioperative period.
Patients will be given standard premedication of paracetamol 1g perorally before surgery: this study does not affect standard surgical treatment.
Paracetamol concentration will be measured in venous plasma-, capillary blood-, and saliva samples before drug delivery and in recovery room after surgery using the novel electrochemical analysis tool and high-performance mass spectrometry analysis as a reference. If needed, confounding medication is identified with large toxicologic mass spectrometry screen (UPLC-QTOF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •Age 18-75 years
- •American society of anesthesiologist classification 2-4
- •planned elective surgery with standard premedication with paracetamol 1g po.
- •at least one regular medication ongoing perioperatively
- •eligibility for elective surgery
- •negative pregnancy test in fertile women
排除标准
- •American society of anesthesiologists classification 1
- •contraindication for use of paracetamol as standard premedication
- •pregnancy or lactation
- •less than 3 months from previous drug research
- •less than 3 months from previous blood donation
- •anticipated difficult puncture of veins
- •Body Mass Index lower than 18.5 or higher than 35
结局指标
主要结局
No outcome for patients
时间窗: 24 hours
Comparison of paracetamol concentration (µmol/L) measurements in saliva-, plasma-, and capillary samples and between mass-spectrometry and electrochemical techniques.
次要结局
未报告次要终点
研究者
Johanna Kujala
Sponsor-Investigator
Helsinki University Central Hospital