Actively Recruiting
Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
Led by Rennes University Hospital · Updated on 2025-05-02
64
Participants Needed
2
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic Study of Intravenous Lidocaine in Young and Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participant aged 40 years or younger, or 70 years or older
- Scheduled for abdominal, digestive, hepatic, urological, or gynecological surgery expected to last more than 2 hours
- Covered by a social security plan
- Received both oral and written information about the study and signed informed consent to participate
You will not qualify if you...
- Allergy to lidocaine or any of its excipients
- Heart failure with ejection fraction less than 45%
- Renal failure with creatinine clearance less than 15 ml/min
- Hepatic failure with prothrombin time less than 15%
- Body Mass Index greater than 30
- Long-term treatment with an antiarrhythmic drug
- Ongoing treatment with strong CYP 1A2 inhibitors or inducers
- Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration
- Known pregnancy or ongoing breastfeeding
- Adults under legal protection or deprived of liberty
- Participation in another interventional study
- Any eligibility criteria no longer met between consent signing and surgery day
- No blood sample available for pharmacokinetic analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CHU de Rennes - Hôpital Pontchaillou
Rennes, CHU de Rennes, France, 35033
Not Yet Recruiting
2
CHU de Rennes - Hôpital Sud
Rennes, France, 35000
Actively Recruiting
Research Team
M
Marie LE NAOU
CONTACT
P
Pauline Rouxel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here