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IRCT20210309050653N1 IRCT 2022-05-25 Shahre-kord University of Medical Sciences Comparison of propofol and sevoflurane with and without remifentanil on anesthesia depth and hemodynamic stability Comparison of propofol and sevoflurane with and without remifentanil on anesthesia depth and hemodynamic stability 2021-11-22 anticipated 80 Complete https://irct.ir/trial/54939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: selection of samples will be with available sampling and attribution of patients to the groups will be done with random allocation software.80 patients who are going to have choleystectomy surgery according to main and inclusion criteria will be considered.patients will be claassified to four group with random allocation software.And it would be clarified that number one or number ten patient should be in which one of these groups and which drug they should recieve, Blinding description: patients are not aware of type of anesthesia drugs.and the anesthesiologist who manages aneshesia is not aware of BIS values and he manages depth of anesthesia according to his clinical experience. 2-3 anesthesia drugs. Intervention 1: Intervention group: patients who recieve sevofluran as a maintenance anesthetic drug.In this group,patients will recieve sevofluran with the dose of almost 3 MAC.The anesthesiologyst may change the dose of sevofluran according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Intervention 2: Intervention group: patients who recieve sevofluran as a maintenance anesthetic drug.In this group,patients will recieve sevofluran with the dose of almost 3 MAC and remifentanil with the dose of 0.2 microgran/kg/min.The anesthesiologyst may change the dose of sevofluran and remifentanil according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Intervention 3: Intervention group: patients who recieve propofol as a maintenance anesthetic drug.In this group,patients will recieve propofol with the dose of 150 microgram/kg/min.The anesthesiologyst may change the dose of propofol according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Intervention 4: Intervention group: patients who recieve propofol and remifentanil as a maintenance anesthetic drug.In this group,patients will recieve propofol with the dose of 150 microgram/kg/min and remifentanil with the dose of 0.2 microgran/kg/min .The anesthesiologyst may change the dose of propofol and remifentanil according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Yes - There is a plan to make this available What will be shared: some parts of data could be shared. When: since 1402 To whom: university researchers Conditions: similar research subject Where to obtain: Elyas Naghib How to obtain: request should be with university email Comments:
public Elyas Naghib
Parastar street,Hafez bulvard
Shahrekord Iran (Islamic Republic of) 8816758915 +98 38 3226 4825 elyasnaghib@yahoo.com Shahre-kord University of Medical Sciences scientific Hossein Madineh
Parastar street,Hafez bulvard
Shahrekord Iran (Islamic Republic of) 8816758915 +98 38 3226 4825 hosseinmadineh@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) all patients with age og 15 to 65 years old GCS of 15 15 years 65 years Both history of addiction BMI more than 30 Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: patients who recieve sevofluran as a maintenance anesthetic drug.In this group,patients will recieve sevofluran with the dose of almost 3 MAC.The anesthesiologyst may change the dose of sevofluran according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Intervention group: patients who recieve sevofluran as a maintenance anesthetic drug.In this group,patients will recieve sevofluran with the dose of almost 3 MAC and remifentanil with the dose of 0.2 microgran/kg/min.The anesthesiologyst may change the dose of sevofluran and remifentanil according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Intervention group: patients who recieve propofol as a maintenance anesthetic drug.In this group,patients will recieve propofol with the dose of 150 microgram/kg/min.The anesthesiologyst may change the dose of propofol according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Intervention group: patients who recieve propofol and remifentanil as a maintenance anesthetic drug.In this group,patients will recieve propofol with the dose of 150 microgram/kg/min and remifentanil with the dose of 0.2 microgran/kg/min .The anesthesiologyst may change the dose of propofol and remifentanil according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values. Bispectral index value. Timepoint: 5 min. Method of measurement: BIS device. Shahre-kord University of Medical Sciences Approved 2021-10-26 Ethics committee of Shahrekord University of Medical Sciences ayatollah kaashani hospital,parastar street,hafez bulvard shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)