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Population pharmacokinetics of propofol in patients undergoing surgical procedure

Protocol summary

Summary
This study intends to characterize propofol pharmacokinetics parameters that it may leads to specifying the ideal dose. Inclusion criteria: ASAclass-1; Age between 15-55 years. Exclusion criteria: ASAclass-2; Addiction; Liver, kidney, cardiac disease; Sensivity for egg; Hemodynamic instability. 30 patients presenting for general anesthesia were enrolled. They were equally divided into two groups: A (50µg/kg/min) and B (100ug/kg/min). All patients were administered same drugs in anesthesia induction with doses according to their weights and followed by a constant infusion rate of propofol. If possible, blood samples were collected at 0, 2, 5, 10, 15, 30, 45, 60 minutes during infusion and then 0, 2, 5, 10, 15, 30, 45, 60, 120, 180 minutes after the stop of infusion. Propofol concentration in plasma were measured using HPLC method..

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013063012365N2
Registration date: 2015-01-01, 1393/10/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-01, 1393/10/11
Registrant information
Name
Saeed Rezaee
Name of organization / entity
Jondishpour university of medical science, faculty of pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 916 301 9067
Email address
s.rezaee@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Population pharmacokinetics of propofol in patients undergoing surgical procedure
Public title
Population pharmacokinetics of propofol infusion
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: ASAclass-1; Age between15-55 years. Exclusion criteria: ASAclass-2; Addiction; Liver, kidney, cardiac disease; Sensivity for egg; Hemodynamic instability.
Age
From 17 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan avenue, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2012-07-21, 1391/04/31
Ethics committee reference number
ETH-542

Health conditions studied

1

Description of health condition studied
General anesthesia
ICD-10 code
Y 48.2
ICD-10 code description
Other and unspecified general anaesthetics

Primary outcomes

1

Description
Plasma concentration of propofol
Timepoint
If possible blood samples are collected at 0, 2, 5, 10, 15, 30, 45, 60 minutes during infusion and then 0, 2, 5, 10, 15, 30, 45, 60, 120, 180 minutes after the end of infusion.
Method of measurement
Blood sampling with the volume of 2ml and analyzing the concentration with HPLC

2

Description
Weight
Timepoint
Before transfering to operation room
Method of measurement
Scale

3

Description
Height
Timepoint
Before transfering to operation room
Method of measurement
Meter

4

Description
Age
Timepoint
Before transfering to operation room
Method of measurement
Match with birth certificate

5

Description
Sex
Timepoint
Before transfering to operation room
Method of measurement
Match with birth certificate

Secondary outcomes

empty

Intervention groups

1

Description
In A group, propofol is infused with infusion rate equals to 50µg/kg/min.
Category
Treatment - Drugs

2

Description
In B group, propofol is infused with infusion rate equals to 100µg/kg/min.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr Mohammad Reza Pipelzadeh
Street address
Imam Khomeini hospital, Azadegan street, Ahvaz, Iran
City
Ahvaz

2

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Mohammad Reza Pipelzadeh
Street address
Golestan hospital, Golestan street, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan avenue, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of pharmacy, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Saeed Rezaee
Position
PhD of pharmaceutics, Assistant professor
Other areas of specialty/work
Street address
School of pharmacy, Ahvaz Jundishapur University of Medical Sciences, Golestan avenue, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 916 301 9067
Fax
Email
s.rezaee@ajums.ac.ir; s.rezaee@live.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of pharmacy, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Saeed Rezaee
Position
PhD of pharmaceutics, Assistant professor
Other areas of specialty/work
Street address
School of pharmacy, Ahvaz Jundishapur of Medical Sciences, Golestan avenue, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 916 301 9067
Fax
Email
s.rezaee@ajums.ac.ir; s.rezaee@live.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of pharmacy, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Saeed Rezaee
Position
PhD of pharmaceutics, Assistant professor
Other areas of specialty/work
Street address
School of pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 916 301 9067
Fax
Email
s.rezaee@ajums.ac.ir; s.rezaee@live.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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