2024-513932-11-00招募中4 期
ElderLIDO_1 : Pharmacokinetic study of intravenous lidocaine in young and elderly patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
研究概览
简要总结
The primary objective of this study is to compare the pharmacokinetics of lidocaine between two groups: a group of young patients and a group of elderly patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult participant (≤ 40 years old) and (≥ 70 years old).
- •Undergoing abdominal, digestive, hepatic, urological, or gynecological surgery with an expected duration > 2 hours.
- •Covered by a social security plan.
- •Provided with both oral and written information about the protocol and has signed informed consent to participate in this research.
排除标准
- •Allergy to lidocaine or any of its excipients.
- •Participant with no blood sample for pharmacokinetics
- •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) >
- •Long-term treatment with a class I (e.g. flecainide, etc.) or III (e.g. Sotalol, amiodarone, etc.) anti-arrhythmic drug
- •Ongoing treatment with strong CYP 1A2 inhibitors (e.g., Ciprofloxacin, Fluvoxamine) and/or CYP 1A2 inducers (e.g., Carbamazepine, Modafinil, Ritonavir).
- •Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration.
- •Known pregnancy or ongoing breastfeeding.
- •Adult under legal protection (e.g., judicial safeguard, guardianship, or tutelage) or deprived of liberty.
- •Participation in another interventional study.
- •Any eligibility criterion that is no longer met between the signing of consent and the day of surgery.
研究者
ROUXEL Pauline
Scientific
Centre Hospitalier Universitaire De Rennes
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
评价 LAE102 注射液不同浓度制剂在中国健康成年参与者中的药代动力学、药效动力学和安全性减重CTR20261219来凯医药科技（上海）有限公司
招募中
1 期
A study to compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 with US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.2025-523115-11-00Chong Kun Dang Pharmaceutical Corp.335
进行中（未招募）
4 期
ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRINCT07346131Hôpital Fribourgeois14
招募中
1 期
A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRIMetastatic Colorectal CancerNCT07543744R-Pharm180
尚未招募
1 期
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male SubjectsMultiple MyelomaNCT07400744Qilu Pharmaceutical Co., Ltd.102