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Health conditions studied
#1
empty
I60
I60
Nontraumatic subarachnoid hemorrhage
Nontraumatic subarachnoid hemorrhage
Craniotomy
Craniotomy
کرانیوتومی
کرانیوتومی
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Haji seyed hosseini
Full name of responsible person - Persian: امین حاجی سید حسینی
Position - English: medicine student
Position - Persian: دانشجو پزشکی
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
Street address - Persian: اراک، سردشت، میدان بسیج، مجتمع پیامبر اعظم (ص)
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3814957558
Phone: +98 86 3222 2003
Mobile: +98 918 161 8210
Fax: +98 86 3222 2003
Email: amin000hoseini@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdi Nikoohemmat
Full name of responsible person - Persian: مهدی نیکوهمت
Position - English: medicine student
Position - Persian: دانشجو پزشکی
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
Street address - Persian: اراک، سردشت، میدان بسیج، مجتمع پیامبر اعظم (ص)
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3814957558
Phone: +98 86 3222 2003
Mobile: +98 936 205 9248
Fax: +98 86 3222 2003
Email: mahdinikoohemmat1994@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Amin Haji seyed hosseiniMahdi Nikoohemmat Full name of responsible person - Persian: امین حاجی سید حسینی مهدی نیکوهمت Position - English: medicine student Position - Persian: دانشجو پزشکی Latest degree: med_doctor Area of specialty/work: 30 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak Street address - Persian: اراک، سردشت، میدان بسیج، مجتمع پیامبر اعظم (ص) City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3814957558 Phone: +98 86 3222 2003 Mobile: +98 918 161 8210936 205 9248 Fax: +98 86 3222 2003 Email: amin000hoseinimahdinikoohemmat1994@yahoo.com Web page address:
Protocol summary
Study aim
Comparison of the effect of Labetalol and Remifentanil and Dexmedetomidine in control of bleeding during Craniotomy
Design
The study will be double blind and clinical trial.90 patients will be randomly divide into 3 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients with Craniotomy in Valiasr hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 75 years, ASA Class One and Two,no coagulation disorders, no history of cardiovascular disease, not addicted to opioids, body mass index more than 35, candidate patients for craniotomy
Exclusion criteria: dissatisfaction with surgery, platelet count less than 150 thousand
Intervention groups
Intervention group 1: A bolus dose of 10 millilitre of normal saline is administered for 10 minutes and then remifentanil is infused at a dose of 0.1 micro gram per kilogram per minute until the end of surgery (GlaxoSmithKline Company (London - England).
Intervention group: 2: 1 micro gram in kilogram Dexmedetomidine will be infused for 10 minutes as the initial dose followed by 0.4 to 0.8 micro gram in kilogram in hours to maintain the infusion dose. (Dexmedetomidine used by Elixir Company - Iran)
Intervention group 3: 0.25 milligram in kilogram Labetalol intravenously as the initial dose is slow and infused within 10 minutes, followed by 1-2 milligram in kilogram intravenously to maintain the infusion dose. (Kern Pharma SL - Spain)
Main outcome variables
Surgeon satisfaction, bleeding, mean hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N167
Registration date:2021-10-14, 1400/07/22
Registration timing:prospective
Last update:2021-10-31, 1400/08/09
Update count:1
Registration date
2021-10-14, 1400/07/22
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
2021-10-23, 1400/08/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Labetalol and Remifentanil and Dexmedetomidine in control of bleeding during Craniotomy
Public title
Comparison of the effect of Labetalol and Remifentanil and Dexmedetomidine in control of bleeding during head surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
ASA Class One and Two
No coagulation disorders
No history of cardiovascular disease
Proper control of blood pressure
Absence of pregnancy
Not addicted to opioids
Body mass index more than 35
Candidate patients for craniotomy
Exclusion criteria:
Dissatisfaction
Existence of allergy to the studied drugs
Platelet count less than 150 thousand
Family history of thromboembolism
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 3 and 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 terms of patient blindness, the intern is responsible for completing information does not know the groupings, and general anesthesia and drug injections are performed by an anesthesiologist.
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern. Also, the patients do not know about their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.ARAKMU.REC.1400.052
Health conditions studied
1
Description of health condition studied
Craniotomy
ICD-10 code
I60
ICD-10 code description
Nontraumatic subarachnoid hemorrhage
Primary outcomes
1
Description
Surgeon satisfaction
Timepoint
After surgery
Method of measurement
Question from the surgeon
2
Description
Bleeding
Timepoint
During surgery
Method of measurement
observation
3
Description
Mean hemoglobin
Timepoint
Before and 12 hours after surgery
Method of measurement
Hemoglobin blood test(CBC diff)
Secondary outcomes
empty
Intervention groups
1
Description
ntervention group 1: A bolus dose of 10 millilitre of normal saline is administered for 10 minutes and then remifentanil is infused at a dose of 0.1 micro gram per kilogram per minute until the end of surgery (GlaxoSmithKline Company (London - England).
Category
Treatment - Drugs
2
Description
Intervention group: 2: 1 micro gram in kilogram Dexmedetomidine will be infused for 10 minutes as the initial dose followed by 0.4 to 0.8 micro gram in kilogram in hours to maintain the infusion dose. (Dexmedetomidine used by Elixir Company - Iran)
Category
Treatment - Drugs
3
Description
Intervention group 3: 0.25 milligram in kilogram Labetalol intravenously as the initial dose is slow and infused within 10 minutes, followed by 1-2 milligram in kilogram intravenously to maintain the infusion dose. (Kern Pharma SL - Spain)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.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 Alireza Kamali
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
alikamaliir@yahoo.com
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