Status:
COMPLETED
Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery
Lead Sponsor:
Fresenius Kabi
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
General Anesthesia
Elective Surgery
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Male or female subjects ≥18 years and \<65 years old
- Able to understand and give signed and dated written informed consent
- Body mass index (BMI) ≥20 and ≤30 kg/m² at screening
- ASA (American Society of Anesthesiologists) physical status 1 or 2
- Undergoing elective, minor orthopedic, vascular, urological, or gynecological surgery
- Patients should be affiliated to a social security scheme and benefit from the corresponding rights and cover
Exclusion
- 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
- 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:
- Clinically significant hypoxia
- Profound hypotension
- Anaphylaxis or anaphylactic reactions
- Unpredictable anesthesia agent requirements
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01856998
Start Date
May 1 2013
Last Update
February 21 2014
Active Locations (1)
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1
CHU de Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, France, 33000