NCT06795100 Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
| NCT ID | NCT06795100 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rennes University Hospital |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-04-28 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) \> 30. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06795100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06795100 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06795100 currently recruiting?
Yes, NCT06795100 is actively recruiting participants. Contact the research team at marie.lenaou@chu-rennes.fr for enrollment information.
Where is the NCT06795100 trial being conducted?
This trial is being conducted at Rennes, France, Rennes, France.
Who is sponsoring the NCT06795100 clinical trial?
NCT06795100 is sponsored by Rennes University Hospital. The trial plans to enroll 64 participants.