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IRCT20201122049464N1 IRCT 2020-12-22 Shahid Beheshti University of Medical Sciences Effects of dexmedetomidine on Postoperative Shivering and nausea and vomiting Effects of dexmedetomidine on Postoperative Shivering and nausea and vomiting in Patients With Opium Addiction After Elective supratentorial Brain tumor Surgeries. 2020-12-17 anticipated 100 Complete https://irct.ir/trial/52489 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 100 opium addicted patients that are candidated for supratentorial brain tumor surgery who have enrollment criteria will be selected. After that we will randomize the patients using a computer-based program with random number generator protocol in two groups of 50 patients ( intervention: dexmedetomidine user and control group: placebo user).The site www.calculator.net will be used for this division.According to the instructions of this site, the lower limit of 1 and the upper limit of 100 will be used and according to the software calculations, the numbers will be given to the patients randomly and the numbers 1-50 and the numbers 51-100 will be in the control group or in the intervention group, Blinding description: The patient who is not responsible for distributing drug, data collecting and analyzing will divide drug and placebo in tho the boxes without name and will code them by A&B. After that this boxes will be administered to the patients by researcher and trained staff and collected data will be delivered to the analyzer. Also the patients will know about this research and will read consent form but they will not know which groups they are in. 3 postoperative shivering , nausea and vomiting. Intervention 1: Intervention group: This group are the patients who are opium addicted and candidated for supratentaria brain tumor surgery that will be revived drug.( infusion of dexmedetomidine 1 mag/kg/min in 10 minutes and 30 minutes before induction.). Intervention 2: Control group: This group are the patients who are opium addicted and candidated for supratentorial brain tumor surgery that will be received placebo ( infusion of normal salin in 10 minutes and 30 minutes before induction). 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 At the end of process we will diced about it.
public Mona Rajabi
No. 6, Banafshe dead end., Sizdah Chenar Ave., Daneshjoo squ
Tehran Iran (Islamic Republic of) 5335054403 009822427554 monarajabi1989@gmail.com Shahid Beheshti University of Medical Sciences scientific Mona Rajabi
No. 6, Banafshe dead end., Sizdah Chenar Ave., Daneshjoo Squ
Tehran Iran (Islamic Republic of) 5335054403 009821224278554 monarajabi1989@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) opium addicted with supratentorial Brain afebrile (normotherm) 18 years 65 years Both not opium addicted febrile with cardiac arrhythmia with history of post operation nausea and vomiting with history of motion sickness with history of GI disease Treatment - Drugs Placebo Intervention group: This group are the patients who are opium addicted and candidated for supratentaria brain tumor surgery that will be revived drug.( infusion of dexmedetomidine 1 mag/kg/min in 10 minutes and 30 minutes before induction.) Control group: This group are the patients who are opium addicted and candidated for supratentorial brain tumor surgery that will be received placebo ( infusion of normal salin in 10 minutes and 30 minutes before induction) Effect of dexmedetomidine on postoperative shivering , nausea and vomiting. Timepoint: Upon arrival to the recovery room till minute 150. Method of measurement: n order to assess research variables such as nausea and vomiting, observation method was applied by the anesthesiologist and a trained nurse during post-operative recovery. Moreover, the Bedside Shivering Assessment Scale (BSAS) was applied to evaluate shivering at the bedside where shivering grades were 2 and 3. Shahid Beheshti University of Medical Sciences Approved 2019-05-12 Ethics committee of Shahid Beheshti University of Medical Science No.2, Arabi Ave, Velenjak Tehran Tehran Iran (Islamic Republic of)