Elective Surgery, General Anesthesia
Conditions
Keywords
Therapeutic Equivalence, Propofol
Brief summary
The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).
Interventions
DRUGPropofol
DRUGDiprivan
Sponsors
Quintiles, Inc.
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects ≥18 years and \<65 years old 2. Able to understand and give signed and dated written informed consent 3. Body mass index (BMI) ≥20 and ≤30 kg/m² at screening 4. ASA (American Society of Anesthesiologists) physical status 1 or 2 5. Undergoing elective, minor orthopedic, vascular, urological, or gynecological surgery 6. Patients should be affiliated to a social security scheme and benefit from the corresponding rights and cover
Exclusion criteria
1. The following planned procedures are to be excluded: * Day surgery * Emergency surgery * Total hip or total knee replacement * Requiring opening of the great cavities of the body (cranium, thorax, peritoneum, or pelvis) * With routine risk, even if low, of hemorrhage severe enough to require administration of colloid or blood products * With routine risk, even if low, of death during or soon after the procedure * Vascular surgery involving the aorta, venae cavae, iliac arteries, or femoral arteries 2. Intended administration of IV medications through a central venous catheter (Note: a central venous catheter may be used to obtain Pharmacokinetic (PK) samples, though only if no port of the catheter is being used for administration of any other product, including crystalloid infusion at more than a keep line open rate) 3. Administration of general anesthesia or propofol within the 7 days prior to randomization 4. History of hypersensitivity to propofol, eggs, soya, peanuts, or any other constituent of the study drugs 5. ASA physical status ≥3 6. History of major anesthesia complications including, but not limited to: * Clinically significant hypoxia * Profound hypotension * Anaphylaxis or anaphylactic reactions * Unpredictable anesthesia agent requirements 7. History of difficult airway management including, but not limited to: * Problematic artificial ventilation with face mask * Repeated difficulty of placement of laryngeal mask airway (LMA) * Difficult laryngeal intubation (Cormack-Lehane grade 3 to 4) and requiring alternative technique e.g. fibre-optic or awake laryngeal intubation 8. History of difficult venous access 9. Myocardial infarction within 6 months of randomization or a cardiac reperfusion procedure within 6 weeks of randomization 10. Significant respiratory, cardiovascular, liver or renal disease as assessed by investigator 11. Active systemic infection (localized infection related to surgical procedure is allowable as long as there is no indication of systemic involvement) 12. History of psychiatric disorder, including use of sedatives or antidepressants for any reason, within 6 months prior to randomization 13. Alcohol or other substance abuse within 2 years prior to randomization, as well as for the duration of the study 14. Use of medication that could reduce the subject's respiratory and/or cardiac output 15. Female subjects who are pregnant, breastfeeding, or lactating 16. Hemoglobin \<7.5 g/dL at screening or randomization 17. Platelets \<50,000 x 10³/μL at screening or randomization 18. ECG findings detected at screening not consistent with the subject's medical history or warranting cardiology review 19. Participation in an interventional clinical study within 6 months of screening 20. History of Propofol infusion syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Loss of Eyelash Reflex (LOER) | Every ten seconds from the initiation of TCI anesthesia device until LOER occurs up to 150 seconds. If LOER has not occurred within this timeframe, target propofol concentration to be increased by 1 μg/mL every 60 seconds until LOER is observed. | The overall timeframe until LOER is observed depends on the patient and varies from only a few seconds up to 240 seconds in total. |
Countries
France
Outcome results
None listed