NCT Number: NCT06795100
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
CHU de Rennes - Hôpital Pontchaillou, Rennes, CHU de Rennes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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
Information and presentation of the proposed study to participants during the anesthesia consultation scheduled prior to surgery, including provision of the information document and consent form. Trial participants will have at least 2 days to decide whether or not to take part in the trial.
Participants will be welcomed according to the usual process in the digestive, hepatic, urological, or gynecological surgery service. The inclusion visit will coincide with the pre-anesthesia visit during which the absence of contraindications for starting the study will be verified, particularly the occurrence of any health changes since the anesthesia visit that would contraindicate anesthesia or lidocaine administration. During this visit, participant consent will be obtained. The informed consent form must be signed no later than the morning of the intervention.
For women of childbearing age, the absence of current pregnancy will be verified orally for each participant included. A pregnancy test may be performed if the participant so wishes, but a systematic test is not justified.
Induction of anesthesia will be at the discretion of the attending anesthesiologist, with a lidocaine bolus of 2 mg/kg administered over 1 minute, followed by a continuous IV infusion of 2 mg/kg/h.
Blood samples of 3 mL will be collected in heparinized tubes without gel of 4 ml at 30, 60 and 120 minutes after the start of lidocaine infusion, then every two hours during surgery, and two finals samples at 15 and 60 minutes after the infusion stops.
. Maximal pain reported in the post-anesthesia care unit (PACU) and maximal pain at rest and with movement at 24 hours post-extubation will be recorded.
Any adverse effects/events will be documented from the start of lidocaine administration until 24 hours post-extubation,
A biological blood test, not performed in routine practice, will be carried out to measure the following parameters: albumin, ASAT, ALAT, PAL, GammaGT, total and conjugated bilirubin, creatinine, with calculation of GFR.
Time frame: at 60 min from initial lidocaine bolus
Plasma concentration of lidocaine at steady state ( at 60 min from initial lidocaine bolus)
Time frame: Day 0
Other pharmacokinetic parameters of lidocaine: clearance
Time frame: Day 0
Other pharmacokinetic parameters of lidocaine: area under the curve (AUC)
Time frame: Day 0
Other pharmacokinetic parameters of lidocaine: plasma half-life
Time frame: Day 0
Other pharmacokinetic parameters of lidocaine: volume of distribution.
Time frame: Day 0
Free concentration of lidocaine.
Time frame: 24 hours post-extubation.
Total morphine-equivalent consumption at 24 hours post-extubation.
Time frame: Day 0
Maximal pain reported in the post-anesthesia care unit (PACU) assessed using the Numerical Rating Scale (NRS) for pain (Numerical scale from 0 to 10 (0: no pain, 10: worst pain ever experienced))
Time frame: 24 hours post-extubation
Maximal pain at rest in the 24h post-extubation, assessed using the Numerical Rating Scale (NRS) for pain. (Numerical scale from 0 to 10 (0: no pain, 10: worst pain ever experienced))
Time frame: 24 hours post-extubation
Maximal pain with movement in the 24h post-extubation, assessed using the Numerical Rating Scale (NRS) for pain (Numerical scale from 0 to 10 (0: no pain, 10: worst pain ever experienced))
Time frame: 24 hours post-extubation
Frequency of adverse effects attributable to lidocaine at 24 hours post-extubation.
Time frame: 24 hours post-extubation
Number of adverse effects attributable to lidocaine at 24 hours post-extubation.
Rennes University Hospital
Other
Acronym: ElderLIDO_1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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