Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Plasma concentration of lidocaine
研究概览
简要总结
Aging is accompanied by a gradual alteration in the functional reserve of several organs and a change in body composition that can affect the pharmacokinetics, response, and safety profile of medications. Lidocaine is a local anesthetic used daily in perineural or intravenous administration to reduce the need for opioids. Although its analgesic efficacy is well-established, there is currently only one older study regarding the pharmacokinetics and pharmacokinetic-pharmacodynamic (PK-PD) relationship of lidocaine in healthy elderly patients. In this study, conducted with a small sample size (13 subjects over 64 years old and 24 young subjects under 38 years old) and using a low bolus of 25 mg, the half-life of lidocaine was increased by 59% and clearance was decreased by 35% in elderly male subjects without significant differences in females. However, the recommendations for intravenous administration of lidocaine for analgesic purposes are the same for all: a bolus of 1 to 2 mg/kg followed by continuous administration of 1.5 to 2 mg/kg/h. Morphine sparing is particularly important in elderly patients due to their increased sensitivity to adverse effects. With this study, the investigators aim to define the optimal dose to administer in elderly subjects, in order to optimize analgesia while remaining within the therapeutic range to limit the adverse effects of lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CI1 - Adult participant (≤ 40 years old) and (≥ 70 years old). CI2 - Undergoing abdominal, digestive, hepatic, urological, or gynecological surgery with an expected duration > 2 hours.
- •CI3 - Covered by a social security plan. CI4 - Provided with both oral and written information about the protocol and has signed informed consent to participate in this research.
排除标准
- •NC1 - Allergy to lidocaine or any of its excipients.
- •NC2 - Presence of comorbidities that may alter lidocaine pharmacokinetics, such as:
- •Heart failure (ejection fraction < 45%).
- •Renal failure (creatinine clearance < 15 ml/min).
- •Hepatic failure (prothrombin time < 15%).
- •Body Mass Index (BMI) >
- •NC3 - Long-term treatment with an antiarrhythmic drug.
- •NC4 - Ongoing treatment with strong CYP 1A2 inhibitors (e.g., Ciprofloxacin, Fluvoxamine) and/or CYP 1A2 inducers (e.g., Carbamazepine, Modafinil, Ritonavir).
- •NC5 - Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration.
- •NC6 - Known pregnancy or ongoing breastfeeding.
- •NC7 - Adult under legal protection (e.g., judicial safeguard, guardianship, or tutelage) or deprived of liberty.
- •NC8 - Participation in another interventional study.
- •EXCLUSION CRITERIA
- •EC1 - Any eligibility criterion that is no longer met between the signing of consent and the day of surgery.
- •EC2 - Participant with no blood sample for pharmacokinetics
研究组 & 干预措施
elderly patients
Adult participant ≥ 70 years old
干预措施: Lidocaine (Drug)
elderly patients
Adult participant ≥ 70 years old
干预措施: Inclusion (Other)
elderly patients
Adult participant ≥ 70 years old
干预措施: Pharmacokinetic study of intravenous lidocaine (Other)
elderly patients
Adult participant ≥ 70 years old
干预措施: Pre-inclusion (Other)
elderly patients
Adult participant ≥ 70 years old
干预措施: Pain (Other)
Young patients
Adult participant ≤ 40 years old)
干预措施: Lidocaine (Drug)
elderly patients
Adult participant ≥ 70 years old
干预措施: biological blood test (Biological)
Young patients
Adult participant ≤ 40 years old)
干预措施: Pre-inclusion (Other)
Young patients
Adult participant ≤ 40 years old)
干预措施: Inclusion (Other)
Young patients
Adult participant ≤ 40 years old)
干预措施: Pain (Other)
Young patients
Adult participant ≤ 40 years old)
干预措施: adverse effects/events (Other)
Young patients
Adult participant ≤ 40 years old)
干预措施: biological blood test (Biological)
elderly patients
Adult participant ≥ 70 years old
干预措施: adverse effects/events (Other)
Young patients
Adult participant ≤ 40 years old)
干预措施: Pharmacokinetic study of intravenous lidocaine (Other)
结局指标
主要结局
Plasma concentration of lidocaine
时间窗: at 60 min from initial lidocaine bolus
Plasma concentration of lidocaine at steady state ( at 60 min from initial lidocaine bolus)
次要结局
- Clearance(Day 0)
- Area under the curve(Day 0)
- plasma half-life(Day 0)
- Volume of distribution(Day 0)
- Free concentration(Day 0)
- Total morphine-equivalent consumption(24 hours post-extubation.)
- Maximal pain reported in the post-anesthesia care unit (PACU)(Day 0)
- Maximal pain at rest in the 24h post-extubation(24 hours post-extubation)
- Maximal pain with movement in the 24h post-extubation(24 hours post-extubation)
- Frequency of adverse effects(24 hours post-extubation)
- Number of adverse effects(24 hours post-extubation)