Evaluation the effects and risks of using propofol in patients admitted to the intensive care unit of Masih Daneshvari Hospital.
Design
Patients' information in the first three years of this study is related to the cases that treated with propofol & in the next eight years, it is related to patients that Propofol has not been used in the treatment. A random selection of patients were performed from both groups. Their data were recorded from their records and compared to demographic characteristics and variables such as: cardiac output, hypertension, hyperlipidemia, sepsis.
Settings and conduct
This study conducted in surgical Intensive Care Unit in Masih Daneshvari Hospital, Tehran, Iran. Patients' information in the first three years of this study is related to the cases that treated with propofol & In the next eight years, it is related to patients that Propofol has not been used in the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients need a sedative in the intensive care unit.
Exclusion criteria: patients with propofol sensivity; patients with certain underlying conditions
Intervention groups
Patients treated with propofol and without propofol
Main outcome variables
Evaluate the effects and risks of using propofol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N19
Registration date:2018-07-29, 1397/05/07
Registration timing:retrospective
Last update:2018-07-29, 1397/05/07
Update count:0
Registration date
2018-07-29, 1397/05/07
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the characteristics of patients treated with and without Propofol in the intensive care unit of MasihDaneshvari Hospital.
Public title
Comparison of the characteristics of patients treated with and without Propofol
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients need a sedative in the intensive care unit
Exclusion criteria:
Patients with propofol sensivity
Patients with certain underlying conditions
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
500
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Masih Daneshvari Hospital the Edjucational , Research and Treatment center.
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
IR.SBMU.MSP.REC.1396.747
Health conditions studied
1
Description of health condition studied
Patients treated with and without Propofol in the intensive care unit.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluate the effects and risks of using propofol.
Timepoint
After using propofol
Method of measurement
The checklist includes demographic features and variables such as cardiac output, hypotension, hyperlipidemia, and sepsis.
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and after the intervention.
Method of measurement
Barometer
2
Description
Cardiac Output
Timepoint
Before and after intervention
Method of measurement
monitoring
Intervention groups
1
Description
Intervention group: treated with Propofol 10%. The drug that is used as a short intravenous injection method and it reduces the level of consciousness or anesthesia. For adult patients, it is advisable to use low doses for intravenous infusion and, after ensuring the stability of the hemodynamic, the dose was increased. In this study, 2.5 mg / kg anesthetic dose of propofol was induced and propofol was used for prolonged relief of 0.1 mg / kg / min.
Category
Treatment - Drugs
2
Description
Control group: Treated without Propofol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohammad Reza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2111 9279
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Edjucational , Research and Treatment center
Full name of responsible person
Seyyed Mohammad Reza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
iran.critcalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Edjucational , Research and Treatment center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The Edjucational , Research and Treatment center
Full name of responsible person
Seyyed Mohammad Reza Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
iran.criticalcare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Edjucational , Research and Treatment center
Full name of responsible person
Seyed Mohamad Reza Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2111 9279
Email
iran.criticalcare@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The Edjucational , Research and Treatment center
Full name of responsible person
Somayeh Aakhavan
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
somayehakhavan30@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available