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

NCT01856998 | Completed Phase 3

• 2 other identifiers: PROP-001-CP32012-005701-43
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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).

Conditions

General Anesthesia; Elective Surgery

Keywords

Therapeutic Equivalence; Propofol

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Drug: Diprivan

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

Drug: Propofol

Interventions

Propofol DRUG

Propofol 2% (20 mg/mL) MCT Fresenius

Diprivan DRUG

Diprivan® 20 mg/mL (AstraZeneca)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

CHU de Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Francois Sztark, Professor

  CHU de Bordeaux, Groupe Hospitalier Pellegrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

FR (1)