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IRCT20190417043302N1 IRCT 2019-05-12 Arak University of Medical Sciences efficacy of Dexmedetomidine and metoral on reducing hemorrhage during craniotomy Comparison of the effect of Dexmedetomidine and Metoprolol on reducing intraoperative bleeding in patients with craniotomy candidate due to head trauma 2018-05-13 anticipated 66 Complete https://irct.ir/trial/39034 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random number table in division of groups in two groups A and B . Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers, Blinding description: The participants will not be informed about the drug administered; however, informed written consent will be obtained from the legal gurdian before enrollment in the study. Drugs will be prepared by the anesthisiologist in 5 ml and 20 ml syringes for both groups and labelled A and B. The anonymous syringes will then be given to an anesthesiology resident for administration. Moreover, the intern responsible for the project will also fill out the questionnaires and document data as groups A and B. Therefore, both the anesthesiology resident and intern will be blinded to group assignment and drug administration. 2 Craniotomy. Intervention 1: Intervention group: Intervention group 1:We inject 1 micro gram in kilogram Dexmedetomidine in loading dose ‏ and 0.5 micro gram in kilogram Dexmedetomidine in hours in Infusion. Intervention 2: Intervention group: Intervention group 2:We inject 2/5 milligram in kilogram Metoprolol in loading dose‏ ‏ and 0.5 micro gram in kilogram Metoprolol in hours in Infusion. Intervention 3: Control group: We inject 5 milliliter distilled water as loading dose and 120 milliliter distilled water in Infusion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet
public Dr Alireza Kamali
Valiasr hospital, Valiasr squre
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Alireza Kamali
Valiasr hospital, Valiasr squre
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients with head trauma Patients with ASA class I and II Patients that the informed written consent form has been fillede out by their legal gurdian in order to participate in the study Candidates of craniotomy due to severe head trauma Patients with severe head trauma candidates of craniotomy with a maximum operation duration of 150 min Patients with severe head trauma candidates of craniotomy that are operated by a neurosurgeon Patients with severe head trauma candidates of craniotomy aged between 15-75 years 15 years 75 years Both Patients with severe head trauma candidates of craniotomy which have hypersensitivy to dexmedetomidine and metoprolol Patients with severe head trauma candidates of craniotomy that their legal gurdian refuse the informed written consent for participation in the study. Patients with a past medical history of cardio-vascvular diseases, uncontrolled diabetes, seizure and epilepsy, renal failure, liver failure, coagulation disorders, previous cerebrovascular accident or recent myocardial infarction S08.89 Traumatic amputation of other parts of head Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group 1:We inject 1 micro gram in kilogram Dexmedetomidine in loading dose ‏ and 0.5 micro gram in kilogram Dexmedetomidine in hours in Infusion. Intervention group: Intervention group 2:We inject 2/5 milligram in kilogram Metoprolol in loading dose‏ ‏ and 0.5 micro gram in kilogram Metoprolol in hours in Infusion. Control group: We inject 5 milliliter distilled water as loading dose and 120 milliliter distilled water in Infusion. Bleeding. Timepoint: Every 15 minutes to end of surgery. Method of measurement: Observation. Mortality. Timepoint: After surgery. Method of measurement: observation. Arak University of Medical Sciences Approved 2018-04-29 Ethics committee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)