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IRCT20220528055003N1 IRCT 2022-07-13 Shahid Beheshti University of Medical Sciences Effects of dexmedetomidine and magnesium sulfate in the administration of pituitary surgery anesthesia A Comparison of Dexmedetomidine and Magnesium Sulfate as an Anesthetic Adjuant in trans-Sphenoid pituitary surgery 2022-07-21 anticipated 60 Complete https://irct.ir/trial/63837 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is a simple randomized clinical trial in which people are randomly assigned to study groups; In such a way that the required number of drugs are placed in opaque sealed envelopes that are coded. Each of the codes is also written on a paper, folded and placed inside a box, after entering the operating room, each patient takes out one of the papers from the box, the envelope has the same number as the number inside the selected paper, intervention It is applied to the patient. This work continues until the end of the papers, so that the number of patients reaches the desired volume in the groups, Blinding description: The outcome researcher will be unaware of the grouping of participants and the type of drug injected into patients; Therefore, the rejection of the study flow will remain blind. 2-3 Pain. Intervention 1: Intervention group: Thirty patients who are candidates for pituitary surgery transferred to the operating room of Loghman Hakim Hospital (Tehran) will be included in this group randomly. After injection of anesthesia drugs and intratracheal intubation, they will receive dexmedetomidine in the form of one microgram / kg in ten minutes as a bolus, and until the end of the surgery, they will receive this drug in the form of half a microgram / kg per hour. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for up to 12 hours after surgery. Intervention 2: Intervention group: Thirty patients who are candidates for pituitary surgery transferred to the operating room of Loghman Hakim Hospital (Tehran) will be included in this group randomly. After injecting anesthesia and intubation intubation, they will receive 50 mg / kg magnesium sulfate as a bolus within ten minutes and will receive 15 μg / kg per hour until surgery. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for up to 12 hours after surgery. 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 No further information available.
public Nina Pilevar
Loghman Hakim Hospital, Special Street, South Kargar Street
Tehran Iran (Islamic Republic of) 3696585859 +98 21 5102 5000 Ninapilevar@yahoo.com Shahid Beheshti University of Medical Sciences scientific Nina Pilevar
Loghman Hakim Hospital, Special Street, South Kargar Street
Tehran Iran (Islamic Republic of) 3696585859 +98 21 5102 5000 Ninapilevar@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidate for pituitary surgery by trans-sphenoid method Candidate for general anesthesia Satisfaction to participate in the study 18 years 75 years Both Sensitivity to the studied drugs Taking drugs that increase intracranial pressure G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Intervention group: Thirty patients who are candidates for pituitary surgery transferred to the operating room of Loghman Hakim Hospital (Tehran) will be included in this group randomly. After injection of anesthesia drugs and intratracheal intubation, they will receive dexmedetomidine in the form of one microgram / kg in ten minutes as a bolus, and until the end of the surgery, they will receive this drug in the form of half a microgram / kg per hour. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for up to 12 hours after surgery. Intervention group: Thirty patients who are candidates for pituitary surgery transferred to the operating room of Loghman Hakim Hospital (Tehran) will be included in this group randomly. After injecting anesthesia and intubation intubation, they will receive 50 mg / kg magnesium sulfate as a bolus within ten minutes and will receive 15 μg / kg per hour until surgery. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for up to 12 hours after surgery. Pain. Timepoint: Up to 12 hours after the intervention and once every hour. Method of measurement: Visual Analog Scale. Hemodynamic status. Timepoint: From the beginning of the intervention to the end of the intervention (every three minutes). Method of measurement: Monitoring hemodynamic status with the help of cardiopulmonary monitoring. Shahid Beheshti University of Medical Sciences Approved 2020-06-28 Ethics Committee of Shahid Beheshti University of Medical Sciences Loghman hakim Hospital. Makhsoos Ane, Southern Karehar Ave Tehran Tehran Iran (Islamic Republic of)