Comparison the effect of dexmetedomidin, magnesium sulfate and osmolol for hypotension control in patients who are candidate for craniotomy surgery because of head injury
Aim of this study is comparison the effect of dexmetedomidin, magnesium sulfate and osmolol for hypotension control in patients who are candidate for craniotomy surgery because of head injury
Design
This study is clinical trial and double blind. 45 Patients with head injury who are candidates for craniotomy and referred to the Vali Asr Hospital in Arak.
Settings and conduct
This study is clinical trial and double blind. 45 Patients with head injury who are candidates for craniotomy and referred to the Vali asr Hospital in Arak.We divide patients in 3 groups randomly.This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Craniotomy candidate, both of gender
Exclusion criteria: Dissatisfaction
Intervention groups
We inject 1 milligram in kilogram Dexmedetomidin in Dexmedetomidin group, 1 milligram in kilogram osmolol in osmolol group, 50 milligram in kilogram in 100 milliliter normal saline as loading dose and we inject 0/5 milligram in kilogram in hours Dexmedetomidin infusion, 0/5 milligram in kilogram in hours osmolol infusion, 15 milligram in kilogram in hours magnesium sulfate infusion in each group.
Main outcome variables
heart rate, blood pressure, bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N86
Registration date:2018-10-07, 1397/07/15
Registration timing:registered_while_recruiting
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of dexmetedomidin, magnesium sulfate and osmolol for hypotension control in patients who are candidate for craniotomy surgery because of head injury
Public title
Comparison the effect of dexmetedomidin, magnesium sulfate and osmolol for hypotension control in patients who are candidate for craniotomy surgery because of head injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Craniotomy candidate
both of gender
Exclusion criteria:
Dissatisfaction
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.ARAKMU.REC.1396.267
Health conditions studied
1
Description of health condition studied
Craniotomy
ICD-10 code
S00
ICD-10 code description
Superficial injury of head
Primary outcomes
1
Description
Heart rate
Timepoint
Every 15 minutes until the end of surgery
Method of measurement
Count
2
Description
Blood pressure
Timepoint
Every 15 minutes until the end of surgery
Method of measurement
Barometer
3
Description
Bleeding
Timepoint
Every 15 minutes until the end of surgery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 1 milligram in kilogram Dexmedetomidin in Dexmedetomidin group as loading dose and after Intubation we inject 0/5 milligram in kilogram in hours Dexmedetomidin infusion.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 1 milligram in kilogram osmolol in 10 milliliter normal salin in osmolol group as loading dose and after Intubation we inject 0/5 milligram in kilogram in hours osmolol infusion.
Category
Treatment - Drugs
3
Description
Intervention group: We inject 50 milligram in kilogram in 100 milliliter normal saline as loading dose and after Intubation we inject 15 milligram in kilogram in hours magnesium sulfate infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Valiasr Hospital, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University Of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street