The study is performed on healthy volunteers, investigating lipid resuscitation from local anesthetic intoxication. MedDRA version: 12.1 Level: LLT Classification code 10066766 Term: Acute drug intoxication
Conditions
Interventions
Trade Name: Intralipid 200 mg/ml
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Sojae ol. purif.
CAS Number: 8001227
Other descriptive name: SOYA OIL
Concentration unit: mg/ml milligra
Sponsors
Per Rosenberg
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male -Age 33-55 -Anesthetists or nurse anesthetists 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Chronic diseases, especially cardiac or lung.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measuring the evolution of plasma bupivacaine concentration over time concurrently with a lipid emulsion infusion.;Secondary Objective: Measuring the possible sedation and cardiac effects of intravenous bupivacaine.;Primary end point(s): Plasma bupivacaine concentrations at the start of the experiment, after 1 mg/kg slow infusion of bupivacaine, 5, 10, 20 and 30 minutes after the end of the bupivacainen infusion during the lipid emulsion infusion. | — |
Countries
Finland
Outcome results
None listed