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ElderLIDO_1 : Pharmacokinetic study of intravenous lidocaine in young and elderly patients
EU CTIS ID: 2024-513932-11-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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) > 30.
- 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.
See the full eligibility criteria
- 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.
- 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) > 30.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.