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IRCT20141209020258N167 IRCT 2021-10-14 Vice chancellor for research, Arak University Of Medical Sciences Comparison of the effect of ‏Labetalol and Remifentanil and Dexmedetomidine in control of ‎bleeding during head surgery Comparison of the effect of‎‏ ‏Labetalol and Remifentanil and Dexmedetomidine in control of ‎bleeding during Craniotomy 2021-10-23 anticipated 90 Complete https://irct.ir/trial/57731 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Craniotomy. Intervention 1: 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). Intervention 2: 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 3: 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). 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 Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific 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 Iran (Islamic Republic of) 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 18 years 75 years Both Dissatisfaction Existence of allergy to the studied drugs Platelet count less than 150 thousand Family history of thromboembolism I60 Nontraumatic subarachnoid hemorrhage Treatment - Drugs Treatment - Drugs Treatment - Drugs 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). 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) Surgeon satisfaction. Timepoint: After surgery. Method of measurement: Question from the surgeon. Bleeding. Timepoint: During surgery. Method of measurement: observation. Mean hemoglobin. Timepoint: Before and 12 hours after surgery. Method of measurement: Hemoglobin blood test(CBC diff). Vice chancellor for research, Arak University Of Medical Sciences Approved 2021-06-13 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)