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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01856998
Other study ID # PROP-001-CP3
Secondary ID 2012-005701-43
Status Completed
Phase Phase 3
First received May 8, 2013
Last updated February 20, 2014
Start date May 2013

Study information

Verified date February 2014
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Propofol

Diprivan


Locations

Country Name City State
France CHU de Bordeaux, Groupe Hospitalier Pellegrin Bordeaux

Sponsors (2)

Lead Sponsor Collaborator
Fresenius Kabi Quintiles, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
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