Pharmacokinetics of Intravenous Lidocaine Hydrochloride in Young and Elderly Patients Undergoing Anesthesia

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What is this study about?

This clinical trial is studying lidocaine hydrochloride, given by vein, in people having anesthesia. The purpose of the study is to compare how the body handles lidocaine in young patients and in elderly patients. The study looks at how much of the drug is present in the blood over time and how it moves through the body.

In the study, lidocaine is given as a continuous infusion during the anesthesia period. Blood samples are taken at different times so that the amount of lidocaine in the blood can be checked. The study also follows pain after surgery and any side effects that may be related to lidocaine, as well as the use of pain medicine after the procedure.

The information from this trial may help improve understanding of how age can change the effect and behavior of lidocaine in the body. This may support safer and more appropriate use of the drug in different age groups.

1 study treatment begins

After joining the study, you receive lidocaine hydrochloride by intravenous infusion, which means it is given through a vein.

The dose is 2 mg/kg/h, which means 2 milligrams per kilogram of body weight each hour.

This medicine is given during the study period as part of the trial treatment.

2 blood lidocaine level measurement

Your blood lidocaine level is checked to measure the amount of medicine in the blood at steady state. This means the level has become stable after ongoing dosing.

These results are used to compare how lidocaine behaves in young and elderly patients.

3 other medicine behavior measurements

The study also measures how lidocaine moves through your body, including clearance (how fast the body removes the medicine), area under the curve (AUC) (the total amount of medicine in the blood over time), plasma half-life (the time it takes for the amount in the blood to decrease by half), and volume of distribution (how widely the medicine spreads in the body).

The study measures the free concentration of lidocaine, which is the part of the medicine that is not attached to blood proteins and can act in the body.

4 after extubation follow-up

At 24 hours after extubation, meaning 24 hours after the breathing tube is removed, the study records the total amount of morphine-equivalent medicine used. Morphine-equivalent means the pain medicine amount is converted into a common measure based on morphine.

Pain is checked in the post-anesthesia care unit (PACU), which is the recovery area after anesthesia. Pain is also checked at rest and with movement during the 24 hours after extubation.

Pain is measured using the numerical rating scale (NRS), which is a pain scale used to rate pain intensity.

Any adverse effects, which means unwanted effects from lidocaine, are recorded during the 24 hours after extubation.

5 end of study assessments

The study ends after the recorded assessments are complete.

The collected information is used to compare lidocaine between young and elderly patients and to help build a model that estimates how factors such as age affect lidocaine behavior in the body.

Who Can Join the Study?

Be an adult in one of the study age groups: 40 years old or younger, or 70 years old or older.
Be scheduled to have abdominal, digestive, liver (hepatic), urinary system (urological), or female reproductive (gynecological) surgery.
The planned surgery must be expected to last more than 2 hours.
Be covered by a social security plan, meaning the person has formal health coverage or insurance of this type.
Have received both oral information and written information about the study.
Have signed the informed consent, which means the person agrees to take part after understanding the study information.

Who Cannot Join the Study?

Having an allergy to lidocaine or to any of the other ingredients in the medicine.
Not having a blood sample available for the pharmacokinetics test, which measures how the body absorbs, uses, and removes the medicine.
Having heart failure with an ejection fraction below 45%. The ejection fraction is the percentage of blood the heart pumps out with each beat.
Having kidney failure with creatinine clearance below 15 mL/min. Creatinine clearance is a test that shows how well the kidneys filter blood.
Having liver failure with prothrombin time below 15%. Prothrombin time is a blood test that helps show how well the liver is working to make clotting proteins.
Having a body mass index (BMI) above 30. BMI is a number based on height and weight.
Taking an anti-arrhythmic medicine of class I or class III for a long time. These are medicines used to control abnormal heart rhythms, such as flecainide, sotalol, or amiodarone.
Using strong CYP 1A2 inhibitors or CYP 1A2 inducers. These are medicines that can change how the body processes other drugs, such as ciprofloxacin, fluvoxamine, carbamazepine, modafinil, or ritonavir.
Receiving peripheral regional anesthesia, neuraxial anesthesia, or local anesthetic infiltration. These are methods of numbing part of the body with an anesthetic medicine.
Being known to be pregnant or currently breastfeeding.
Being an adult under legal protection, such as under guardianship or judicial supervision, or being deprived of liberty.
Taking part in another interventional study, which means another research study that gives a treatment or procedure.
No longer meeting any of the study requirements between signing the consent form and the day of surgery.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Rennes	Rennes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

Lidocaine Hydrochloride

Lidocaine is given through a vein in this study. It is the medicine being tested to see how the body handles it in younger and older patients. Researchers want to understand how quickly lidocaine moves through the body, how long it stays there, and whether age changes the way the body processes it.

Anesthesia – A state of controlled loss of sensation, often with reduced awareness, used during medical procedures. It can be general, affecting the whole body and consciousness, or local, affecting only a specific area. The state begins with the administration of anesthetic agents and gradually ends as the drug leaves the body and normal sensation returns.

Trial ID:

2024-513932-11-00

Protocol code:

35RC23_9774-07

Trial Phase:

Therapeutic confirmatory (Phase III)

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Pharmacokinetics of Intravenous Lidocaine Hydrochloride in Young and Elderly Patients Undergoing Anesthesia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?