Comparing the effects of Dexmedetomidine and Metoprolol and Magnesium Sulphate in ReducingBlood Loss during Craniotomy
Design
A double-blind clinical trial study, 99 patients were randomly divided into 3 groups. The groups are in parallel. The trial phase is 3.
Settings and conduct
Candidates for general anesthesia in Valiasr hospital in Arak city are divided into 3 groups by simple randomization using block method. The study is double-blind. In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the interns do not know about the prescribed drugs, and the follow-up of the patients is with the interns, and the analyst does not know about the grouping, and as a result The study will be double-blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 75 years; ASA class one and two; not suffering from coagulation disorders; no history of cardiovascular diseases; Body mass index less than 35; craniotomy candidate patients; having consent to enter the study; Absence of sensitivity to the study drugs
Intervention groups
Intervention group 1: 1 μg/kg of dexmedetomidine for 10 minutes as an initial dose, followed by 0.4 to 0.8 μg/kg per hour for maintenance dose. (Consumable dexmedetomidine is made by Elixir - Iran)
Intervention group 2: The initial dose of 2.5 mg/kg and then 0.5 mg/kg per hour of metoprolol will be infused. (Alborz Daru Pharmaceutical Company - Made in Iran)
Intervention group 3: The initial dose of magnesium sulfate 40 mg/kg of magnesium sulfate (magnesium sulfate 50%, one gram in 2 ml) will be infused in 30 minutes and then 10 mg/kg per hour will be infused. (Pharmaceutical company) Shahid Ghazi - Made in Iran)
Main outcome variables
Average hemoglobin, bleeding, surgeon satisfaction, recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N188
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
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
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Dexmedetomidine and Metoprolol and Magnesium Sulphate in ReducingBlood Loss during Craniotomy
Public title
Comparing the effects of Dexmedetomidine and Metoprolol and Magnesium Sulphate in ReducingBlood Loss during Craniotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
ASA class Iand II
Absence of coagulation disorders
No history of cardiovascular diseases
Proper control of blood pressure
Absence of pregnancy
No addiction to opioids
Body mass index less than 35
Craniotomy candidate patients
Having consent to enter the study
Absence of sensitivity to the study drugs
The presence of creatinine less than 1/5
Absence of platelet count less than 150 thousand
Serum magnesium is less than or equal to 2.5
Exclusion criteria:
Dissatisfaction
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 3 groups(intervention) using a permuted balanced block randomization method with the size of blocks 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the interns do not know about the prescribed drugs, and the follow-up of the patients is with the interns, and the analyst does not know about the grouping, and as a result, the study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.ARAKMU.REC.1402.105
Health conditions studied
1
Description of health condition studied
Craniotomy surgery
ICD-10 code
Q00.1
ICD-10 code description
Craniorachischisis
Primary outcomes
1
Description
Average hemoglobin
Timepoint
Before and 12 hours after surgery
Method of measurement
Blood test
2
Description
Bleeding
Timepoint
during surgery
Method of measurement
Based on scoring 1 to 4 bleeding volume
3
Description
Consent of the surgeon
Timepoint
After surgery
Method of measurement
Score 3 points(zero means bad, one means average and two means good)
4
Description
Recovery time
Timepoint
End of study
Method of measurement
chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 1 μg/kg of dexmedetomidine for 10 minutes as an initial dose, followed by 0.4 to 0.8 μg/kg per hour for maintenance dose. (Consumable dexmedetomidine is made by Elixir - Iran)
Category
Treatment - Drugs
2
Description
Intervention group 2: The initial dose of 2.5 mg/kg and then 0.5 mg/kg per hour of metoprolol will be infused. (Alborz Daru Pharmaceutical Company - Made in Iran)
Category
Treatment - Drugs
3
Description
Intervention group 3: The initial dose of magnesium sulfate 40 mg/kg of magnesium sulfate (magnesium sulfate 50%, one gram in 2 ml) will be infused in 30 minutes and then 10 mg/kg per hour will be infused. (Pharmaceutical company) Shahid Ghazi - Made in Iran)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davoud Hekmatpou
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hekmatpou@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Hesamedin Modir
Position
Associate 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
Email
modir.he@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street