ElderLIDO_1 : Pharmacokinetic study of intravenous lidocaine in young and elderly patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Rennes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

28 Apr 2025 → ongoing

Decision date (initial)

2025-01-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Research and Innovation Department (DRI) of Rennes University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

The primary objective of this study is to compare the pharmacokinetics of lidocaine between two groups: a group of young patients and a group of elderly patients.

Secondary objectives 6

1. Identification of covariates responsible for pharmacokinetic variations.
2. Measurement of the free concentration of lidocaine.
3. Assessment of postoperative opioid consumption.
4. Evaluation of postoperative pain.
5. Examination of the relationship between lidocaine exposure and the occurrence of adverse drug reactions.
6. Development of a dosing algorithm to tailor lidocaine doses based on patient characteristics.

Conditions and MedDRA coding

Anesthesia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 10

1. Allergy to lidocaine or any of its excipients.
2. 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.
3. Long-term treatment with a class I (e.g. flecainide, etc.) or III (e.g. Sotalol, amiodarone, etc.) anti-arrhythmic drug
4. Ongoing treatment with strong CYP 1A2 inhibitors (e.g., Ciprofloxacin, Fluvoxamine) and/or CYP 1A2 inducers (e.g., Carbamazepine, Modafinil, Ritonavir).
5. Use of peripheral or neuraxial regional anesthesia or local anesthetic infiltration.
6. Known pregnancy or ongoing breastfeeding.
7. Adult under legal protection (e.g., judicial safeguard, guardianship, or tutelage) or deprived of liberty.
8. Participation in another interventional study.
9. Any eligibility criterion that is no longer met between the signing of consent and the day of surgery.
10. Participant with no blood sample for pharmacokinetics

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Plasma concentration of lidocaine at steady state

Secondary endpoints 6

1. Other pharmacokinetic parameters of lidocaine: clearance, area under the curve (AUC), plasma half-life, and volume of distribution.
2. Free concentration of lidocaine.
3. Total morphine-equivalent consumption at 24 hours post-extubation.
4. 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.
5. Frequency and number of adverse effects attributable to lidocaine at 24 hours post-extubation.
6. Development of a model to estimate the influence of covariates, including age, on the pharmacokinetics of lidocaine.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Rennes

Sponsor organisation

Centre Hospitalier Universitaire De Rennes

Address

2 Rue Henri Le Guilloux

City

Rennes

Postcode

35000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

ROUXEL Pauline

Public contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

ROUXEL Pauline

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications