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IRCT20141209020258N188 IRCT 2023-09-13 Arak University of Medical Sciences Comparing the effects of Dexmedetomidine and Metoprolol and Magnesium Sulphate in ReducingBlood Loss during Craniotomy Comparing the effects of Dexmedetomidine and Metoprolol and Magnesium Sulphate in ReducingBlood Loss during Craniotomy 2023-09-23 anticipated 99 Complete https://irct.ir/trial/72482 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Craniotomy surgery. Intervention 1: 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 2: 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 3: 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). 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 There is no more information.
public Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Behnam Mahmodie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mahmodie@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both Dissatisfaction Q00.1 Craniorachischisis Treatment - Drugs Treatment - Drugs Treatment - Drugs 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) Average hemoglobin. Timepoint: Before and 12 hours after surgery. Method of measurement: Blood test. Bleeding. Timepoint: during surgery. Method of measurement: Based on scoring 1 to 4 bleeding volume. Consent of the surgeon. Timepoint: After surgery. Method of measurement: Score 3 points(zero means bad, one means average and two means good). Recovery time. Timepoint: End of study. Method of measurement: chronometer. Arak University of Medical Sciences Approved 2023-07-04 Ethics committee Arak University Of Medical Sciences Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)