Clinical trial NCT06795100: Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
Official title: Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Primary outcomes:
measure: Plasma concentration of lidocaine
timeFrame: at 60 min from initial lidocaine bolus
Secondary outcomes:
measure: Clearance
timeFrame: Day 0
measure: Area under the curve
timeFrame: Day 0
measure: plasma half-life
timeFrame: Day 0
measure: Volume of distribution
timeFrame: Day 0
measure: Free concentration
timeFrame: Day 0
measure: Total morphine-equivalent consumption
timeFrame: 24 hours post-extubation.
measure: Maximal pain reported in the post-anesthesia care unit (PACU)
timeFrame: Day 0
measure: Maximal pain at rest in the 24h post-extubation
timeFrame: 24 hours post-extubation
measure: Maximal pain with movement in the 24h post-extubation
timeFrame: 24 hours post-extubation
measure: Frequency of adverse effects
timeFrame: 24 hours post-extubation
measure: Number of adverse effects
timeFrame: 24 hours post-extubation
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
state: CHU De Rennes
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Sud
Study officials:
References: