Comparison of the efficacy of intravenous propofol infusion with conservative treatment in outcome of patients with severe intracerebral hemorrhage hospital based
Comparison of the efficasy of 24-hour intravenous propofol infusion with conservative treatment in outcome of patients with severe intracerebral hemorrhage
Design
After selecting the patients and explaining the study and the purposes of the study for their legal status, written consent was obtained and patients randomly assigned to the study will be divided into two groups receiving propofol infusion and control group patients.
Settings and conduct
After obtaining permission from the Ethics Committee of Qom University of Medical Sciences, the present study will be conducted in a clinical trial in patients with intracerebral hemorrhage who are not candidates for craniotomy. The implementation of this research project will be undertaken with the informed consent of the study and the medicines and their effects on all patients or their relatives, and it will be possible to withdraw from the study at any time without difficulty.
The study site of the teaching hospitals in Qom city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patients with acute ICH aged 15 years or older
• Having a NIHSS score above 15
• No surgical indication by the neurosurgical team
Exclusion criteria:
• A history of allergy to the drugs used in the study
• Pregnancy and lactation
• Chronic renal failure, liver or any concomitant chronic illness
• Concomitant malignancy
Intervention groups
The present study will be a clinical trial on patients with severe intracerebral hemorrhage (NIHSS> 15) who are not candidates for craniotomy. The experimental group will receive propofol intravenous infusion at a dose of 75-75 µg / kg / min for the first 24 hours in addition to the usual care and treatment used in the control group.
Main outcome variables
Mean mRS; NIHSS; mortality rate; length of hospitalization; intubation time; extent of bleeding; rate of edema and bleeding complications
General information
Reason for update
Acronym
ICH( intracerebral hemorrhage)
IRCT registration information
IRCT registration number:IRCT20200208046414N1
Registration date:2020-04-04, 1399/01/16
Registration timing:prospective
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Farideh Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 3297
Email address
dr.farideh.z92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intravenous propofol infusion with conservative treatment in outcome of patients with severe intracerebral hemorrhage hospital based
Public title
"Effect of propofol in severe intracerebral hemorrhage "
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute ICH over 15 years of ages
No surgery indication by the neurosurgery team
NIHSS above 15
Exclusion criteria:
Pregnancy &lactation
Concurrent Malignancy
CKD or chronic hepatic failure or another chronic sickness
History of drug sensitivity used in the study
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
At all stages of the study, the researchers responsible for evaluating the outcome of the patients would be blind to the grouping performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
In addition to routine treatment and care, a 25-75 µg / kg / min intravenous infusion will be used within the first 24 hours. NIHSS, GCS and bleeding volume will be recorded on arrival and daily for up to 7 days. Also, mortality rate, duration of hospitalization, extent of hemorrhage and mRS, NIHSS, GCS in the group receiving propofol will be compared using appropriate statistical tests. Cardiac wall, measurement of oxygen saturation of peripheral blood by pulse oxy meters, standard neurological treatments and standard rehabilitation measures will be performed.
Category
Treatment - Drugs
2
Description
Control group: In patients of the intervention group routine supportive measures in patients with intracerebral hemorrhage hospitalized in the intensive care unit such as blood pressure measurement, ECG monitoring, measurement of peripheral blood oxygen saturation by pulse oximeter, standard neurological treatments and Standard rehabilitation procedures will be performed. All demographic and clinical information of patients will be recorded in questionnaires designed by researchers and the amount of mRS, NIHSS, GCS and bleeding volume will be recorded at the beginning of the day and up to 7 days. Also, mortality rate, duration of hospitalization, extent of hemorrhage expansion and rate of mRS, NIHSS, GCS in the control group will be compared using appropriate statistical tests. Standard neurological treatments and standard rehabilitation measures will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital complex
Full name of responsible person
Ehsan sharifipour
Street address
Shahid Beheshti St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2000
Email
f.zamani1371@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr Ehsan Sharifipour
Street address
Faculty of Medicine. Pardis Complex. in front of Yadegar Imam Stadium.Ghadir Boulevard
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3320 9071
Email
sharifipour.e@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
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
Ghoum University of Medical Sciences
Full name of responsible person
Dr Ehsan Sharifipour
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Faculty of Medicine. Pardis Complex. in front of Yadegar Imam Stadium.Ghadir Boulevard
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3320 9071
Email
sharifipour.e@muq.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr Ehsan Sharifipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Faculty of Medicine. Pardis Complex. in front of Yadegar Imam Stadium.Ghadir Boulevard
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3320 9071
Email
sharifipour.e@muq.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Farideh Zamani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Faculty of Medicine. Pardis Complex. in front of Yadegar Imam Stadium.Ghadir Boulevard
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3320 9071
Email
dr.farideh.z92@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