Sitooko laskimoon annettu rasvaemulsio laskimoon annettua lidokaiinia? - farmakokineettinen ja neu-rofysiologinen tutkimus terveillä vapaaehtoisilla koehenkilöillä

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001551-39-FI

Enrollment

Registered

2012-09-21

Start date

2012-10-10

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Health volunteers used.

Interventions

Trade Name: Intralipid 200 mg/ml Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Sojae ol. purif. CAS Number: 8001-22-7

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Informed concent Age 20-40 Male Healthy Systolic blood pressure > 100 mmHg Pulse > 45/min Normal ECG Hemoglobine 134-167 g/l, ALAT, AFOS, GT, Krea, K, Na within normal range.e Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Significant morbidity Allergy to substance used in trial Smoking Regular medication Less than 3 months from previous trial Less than 3 months from previous blood donation Significant obesity or bad periferal veins Body mass index < 18.5 kg/m2

Design outcomes

Primary

Measure	Time frame
Main Objective: Measuring the attenuating effect of Intralipid infusion on the EEG effect of a rapid 1 mg/kg lidocaine bolus in healthy volunteers.;Secondary Objective: Measuring whether Intralipid infusion attenuates the side-effects of a rapid 1 mg/kg lidocaine bolus in healthy volunteers.;Primary end point(s): EEG change during 30 minute follow-up and infusion of Intralipid/placebo.;Timepoint(s) of evaluation of this end point: Every 30 s for first 5 min after lidocaine bolus, then until lidocaine effect attenuated.	—

Measure

Time frame

Main Objective: Measuring the attenuating effect of Intralipid infusion on the EEG effect of a rapid 1 mg/kg lidocaine bolus in healthy volunteers.;Secondary Objective: Measuring whether Intralipid infusion attenuates the side-effects of a rapid 1 mg/kg lidocaine bolus in healthy volunteers.;Primary end point(s): EEG change during 30 minute follow-up and infusion of Intralipid/placebo.;Timepoint(s) of evaluation of this end point: Every 30 s for first 5 min after lidocaine bolus, then until lidocaine effect attenuated.

—

Secondary

Measure	Time frame
Secondary end point(s): Side-effects of lidocaine bolus, lidocaine concentrations in repeated blood samples; Timepoint(s) of evaluation of this end point: Side-effects: 5 minutes after lidocaine bolus injection Lidocaine concentration in blood samples: before lidocaine bolus, 1 min, 5 min, 10 min, 20 min, 30 min after lidocaine bolus	—

Countries

Finland

Contacts

Public ContactClinical Trials Information

Erik Litonius

erik@litonius.com358505826268

Outcome results

None listed

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