Comparison pharmacokinetics and pharmacodynanics of two proprietary propofol formulations

Comparision of population pharmacokinetics and pharmacodynamics of two proprietary formulations (Propofol 1% Provive® and Propofol 1% MCT Fresenius®) of propofol in patients under anaesthesia induced and maintained by it.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014113020081N2

Enrollment

Registered

2014-12-24

Start date

2014-01-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anesthesia. Other and unspecified general anaesthetics

Interventions

In B group propofol 1% Provive® is administered for anesthesia induction and maintenance

Intervention 1: In B group propofol 1% Provive® is administered for anesthesia induction and maintenance. Intervention 2: In A group propofol 1% MCT Fresenius ® is administered for anesthesia inducti

Treatment - Drugs

In A group propofol 1% MCT Fresenius ® is administered for anesthesia induction and maintenance

Eligibility

Sex/Gender

All

Age

16 Years to 51 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ASAclass-1; age between15-55 years. Exclusion criteria: ASAclass-2; Addiction; Liver, kidney, cardiac diseas; Sensivity for egg; Pregnancy; Hemodynamic instability.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Plasma concentration of propofol. Timepoint: If possible, blood samples are collected after the bolus dose and at 0-2-5-10-15-30-45-60-90-120-180-240 minutes during infusion and then 0-2-5-10-15-30-45-60-120-180 minutes after the stop of infusion. Method of measurement: Blood sampling with the volume of 2ml and analyzing the concentration with HPLC.;BIS index. Timepoint: if possible every minute, before induction till 30 minute after recovery. Method of measurement: BIS recorder.;Weight. Timepoint: Before transfering to operation room. Method of measurement: Scale.;Height. Timepoint: Before transfering to operation room. Method of measurement: Meter.;Age. Timepoint: Before transfering to operation room. Method of measurement: Match with birth certificate.;Sex. Timepoint: Before transfering to operation room. Method of measurement: Match with birth certificate.	—

Measure

Time frame

Plasma concentration of propofol. Timepoint: If possible, blood samples are collected after the bolus dose and at 0-2-5-10-15-30-45-60-90-120-180-240 minutes during infusion and then 0-2-5-10-15-30-45-60-120-180 minutes after the stop of infusion. Method of measurement: Blood sampling with the volume of 2ml and analyzing the concentration with HPLC.;BIS index. Timepoint: if possible every minute, before induction till 30 minute after recovery. Method of measurement: BIS recorder.;Weight. Timepoint: Before transfering to operation room. Method of measurement: Scale.;Height. Timepoint: Before transfering to operation room. Method of measurement: Meter.;Age. Timepoint: Before transfering to operation room. Method of measurement: Match with birth certificate.;Sex. Timepoint: Before transfering to operation room. Method of measurement: Match with birth certificate.

—

Secondary

Measure	Time frame
Loss of consciousness. Timepoint: From bolus dose until loss of consciousness. Method of measurement: Stop watch.;Recovery time. Timepoint: From stop of propofol infusion untill awakening. Method of measurement: Watch.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Kaveh Behaeen

Ahvaz Jundishapur of Medical Sciences

drbehaeen-k@ajums.ac.irdrbehaeen@yahoo.com+98 61 3222 0168

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026