LIDOCAINE HYDROCHLORIDE for Anesthesia

Inclusion criteria

• {"criterion_text":"- Adult participant (≤ 40 years old) and (≥ 70 years old)."}
• {"criterion_text":"- Undergoing abdominal, digestive, hepatic, urological, or gynecological surgery with an expected duration > 2 hours."}
• {"criterion_text":"- Covered by a social security plan."}
• {"criterion_text":"- Provided with both oral and written information about the protocol and has signed informed consent to participate in this research."}

Exclusion criteria

• {"criterion_text":"- Allergy to lidocaine or any of its excipients."}
• {"criterion_text":"- Participant with no blood sample for pharmacokinetics"}
• {"criterion_text":"- Presence of comorbidities that may alter lidocaine pharmacokinetics, such as: •\tHeart failure (ejection fraction < 45%). •\tRenal failure (creatinine clearance < 15 ml/min). •\tHepatic failure (prothrombin time < 15%). •\tBody Mass Index (BMI) > 30."}
• {"criterion_text":"- Long-term treatment with a class I (e.g. flecainide, etc.) or III (e.g. Sotalol, amiodarone, etc.) anti-arrhythmic drug"}
• {"criterion_text":"- Ongoing treatment with strong CYP 1A2 inhibitors (e.g., Ciprofloxacin, Fluvoxamine) and/or CYP 1A2 inducers (e.g., Carbamazepine, Modafinil, Ritonavir)."}
• {"criterion_text":"- Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration."}
• {"criterion_text":"- Known pregnancy or ongoing breastfeeding."}
• {"criterion_text":"- Adult under legal protection (e.g., judicial safeguard, guardianship, or tutelage) or deprived of liberty."}
• {"criterion_text":"- Participation in another interventional study."}
• {"criterion_text":"- Any eligibility criterion that is no longer met between the signing of consent and the day of surgery."}

Primary endpoints

• {"endpoint_text":"- Plasma concentration of lidocaine at steady state","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Other pharmacokinetic parameters of lidocaine: clearance, area under the curve (AUC), plasma half-life, and volume of distribution.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Free concentration of lidocaine.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Total morphine-equivalent consumption at 24 hours post-extubation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Maximal pain reported in the post-anesthesia care unit (PACU) and maximal pain at rest and with movement in the 24h post-extubation, assessed using the Numerical Rating Scale (NRS) for pain.","definition_or_measurement_approach":"Assessed using the Numerical Rating Scale (NRS) for pain."}
• {"endpoint_text":"- Frequency and number of adverse effects attributable to lidocaine at 24 hours post-extubation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Development of a model to estimate the influence of covariates, including age, on the pharmacokinetics of lidocaine.","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

09-12-2024

Latest Decision Or Authorization Date

03-11-2025

Processing Time Days

329

Number Of Sites

2

Number Of Participants

64

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Rennes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France