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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005701-43 | EudraCT Number |
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diprivan® 20 mg/mL (AstraZeneca) | Active Comparator | Dosage form: lipid emulsion Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery) Duration: Until end of surgery |
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| Propofol 2% (20 mg/mL) MCT Fresenius | Experimental | Dosage form: lipid emulsion Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery) Duration: Until end of surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
| ||
| Diprivan |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Loss of Eyelash Reflex (LOER) | The overall timeframe until LOER is observed depends on the patient and varies from only a few seconds up to 240 seconds in total. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
The following planned procedures are to be excluded:
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)
Administration of general anesthesia or propofol within the 7 days prior to randomization
History of hypersensitivity to propofol, eggs, soya, peanuts, or any other constituent of the study drugs
ASA physical status ≥3
History of major anesthesia complications including, but not limited to:
History of difficult airway management including, but not limited to:
History of difficult venous access
Myocardial infarction within 6 months of randomization or a cardiac reperfusion procedure within 6 weeks of randomization
Significant respiratory, cardiovascular, liver or renal disease as assessed by investigator
Active systemic infection (localized infection related to surgical procedure is allowable as long as there is no indication of systemic involvement)
History of psychiatric disorder, including use of sedatives or antidepressants for any reason, within 6 months prior to randomization
Alcohol or other substance abuse within 2 years prior to randomization, as well as for the duration of the study
Use of medication that could reduce the subject's respiratory and/or cardiac output
Female subjects who are pregnant, breastfeeding, or lactating
Hemoglobin <7.5 g/dL at screening or randomization
Platelets <50,000 x 10³/μL at screening or randomization
ECG findings detected at screening not consistent with the subject's medical history or warranting cardiology review
Participation in an interventional clinical study within 6 months of screening
History of Propofol infusion syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Francois Sztark, Professor | CHU de Bordeaux, Groupe Hospitalier Pellegrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux, Groupe Hospitalier Pellegrin | Bordeaux | 33000 | France |
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|
| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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