Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01856998
• Date of registration: 08/05/2013
• Prospective Registration: No
• Primary sponsor: Fresenius Kabi
• Public title: Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery PropofolTE
• Scientific title: Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared With Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery
• Date of first enrolment: May 2013
• Target sample size: 71
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01856998
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Francois Sztark, Professor
• Affiliation: CHU de Bordeaux, Groupe Hospitalier Pellegrin

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Elective Surgery

General Anesthesia

Intervention(s)

Drug: Diprivan

Drug: Propofol

Primary Outcome(s)

Time to Loss of Eyelash Reflex (LOER) [Time Frame: 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.]

Secondary ID(s)

2012-005701-43

PROP-001-CP3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles