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Population pharmacokinetics of intravenous lidocaine in elderly patients

Population pharmacokinetics of intravenous lidocaine in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074685
Enrollment
Unknown
Registered
2023-08-14
Start date
2023-08-14
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly surgical patients

Interventions

Control group (18-64 years old):Lidocaine 1.5 mg/kg was injected intravenously during anesthesia induction
Experimental group (65-74 years old):Lidocaine 1.5 mg/kg was injected intravenously during anesthesia induction
Experimental group (75-84 years old):Lidocaine 1 mg/kg was injected intravenously during anesthesia induction
Experimental group (=85 years old):Lidocaine 1 mg/kg was injected intravenously during anesthesia induction

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Adult patients aged 18-64 years and patients aged 65-74 years, 75-84 years and older than 85 years; 2.ASA Level I-III; 3.BMI:18.5-24.9 kg/m2; 4. Patients undergoing elective surgery under general anesthesia with tracheal intubation.

Exclusion criteria

Exclusion criteria: 1. Allergic to lidocaine or narcotic drugs; 2. Unable to sign informed consent; 3. Severe hepatic and renal insufficiency; Total bilirubin >1.46mg/dl; Serum creatinine exceeding 2 mg/dL; End-stage liver and kidney disease; 4. Serious heart disease; Severe heart block, sick sinus syndrome, sinus bradycardia, AS syndrome, preexcitation syndrome, etc. 5. Ideal weight (IBW) <40 kg; 6. 2 weeks before the trial or participating in other drug clinical trials; 7. Long-term use of cimetidine, beta blockers and other drugs that affect lidocaine metabolism or aggravate lidocaine adverse reactions; 8. Have a history of epilepsy or mental illness.

Design outcomes

Primary

MeasureTime frame
Lidocaine plasma concentration;Plasma concentrations of lidocaine active metabolites;Maximum peak concentration of the drug in plasma (Cmax);Time to reach maximum concentration (Tmax);Terminal elimination half-life (t1/2);Clearance rates;Apparent distribution volume;Area under the curve (AUC) from time zero to infinity;AUC0-t;

Secondary

MeasureTime frame
Single nucleotide polymorphisms of metabolic enzymes CYP1A2 and CYP3A4;Age, gender, height, weight, ideal weight and body mass index;Biochemical indexes such as liver and kidney function before and after operation;Adverse drug reaction;

Countries

China

Contacts

Public ContactFaping Tu

Affiliated Hospital of North Sichuan Medical College

tfpnc@163.com+86 138 0827 0833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026