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

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

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

NCT01856998•Fresenius Kabi

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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
+24 more criteria

Locations (1)

CHU de Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, France

Key Dates

Start Date

May 1, 2013

Primary Completion Date

February 1, 2014

Last Updated

February 21, 2014

Enrollment

ACTUAL participants

Conditions

General AnesthesiaElective Surgery

Interventions

Propofol

DRUG

Diprivan

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

BIS Variability and Change in Quality of Recovery After Surgery

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