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IRCT20101122005225N10 IRCT 2022-05-09 Tehran University of Medical Sciences The effect of naloxone on hemodynamic factors and bleeding rate in patients under general anesthesia. Comparison of the effect of low-dose naloxone infusion on hemodynamic factors and surgical field bleeding in patients under general anesthesia with remifentanil and propofol infusion. 2022-04-21 anticipated 114 Complete https://irct.ir/trial/62909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block 4, we divide patients into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 3 Head and neck surgery. Intervention 1: Intervention group: This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. In the intervention group, naloxone (manufactured by Tolid darou pharmaceutical company) is prepared in a dose (0.25 g / kg / h) in 10 ml of normal saline and is infused during the operation using a syringe pump. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded 15 minutes after induction and then every 15 minutes until the end of the operation and in recovery .The surgeon's overall satisfaction with the amount of bleeding during the operation at the surgical site is also assessed and recorded. Intervention 2: Control group: This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. In the control group, 10 ml of normal saline is infused using a syringe pump during the operation. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded , 15 minutes after induction and every 15 minutes until the end of the operation and in recovery. The surgeon's overall satisfaction with the amount of bleeding during the operation at the surgical site is also assessed and recorded. 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 Seyed Mohammad Mireskandari
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 2261 8931 mireskandari@sina.tums.ac.ir Tehran University of Medical Sciences scientific Seyed Mohammad Mireskandari
No4, Yasaman Alley, Goleyakh Alley, Basiri St., Shariati Ave., Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 2261 8931 mireskandari@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing head and neck surgery 18 years 65 years Both Patients addicted to Narcotics Patients with heart failure or advanced heart disease Patients with asthma C82.51 Diffuse follicle center lymphoma, lymph nodes of head, face, and neck Treatment - Drugs Placebo Intervention group: This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. In the intervention group, naloxone (manufactured by Tolid darou pharmaceutical company) is prepared in a dose (0.25 g / kg / h) in 10 ml of normal saline and is infused during the operation using a syringe pump. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded 15 minutes after induction and then every 15 minutes until the end of the operation and in recovery .The surgeon's overall satisfaction with the amount of bleeding during the operation at the surgical site is also assessed and recorded. Control group: This study is a randomized clinical trial and will be performed after the approval of the ethics committee of Tehran University of Medical Sciences. After prescribing premedication and standard monitoring, induction of anesthesia is performed. In the control group, 10 ml of normal saline is infused using a syringe pump during the operation. Systolic and diastolic blood pressure, heart rate in the time before induction are recorded, then systolic and diastolic blood pressure, heart rate, cardiac output, stroke volume are recorded , 15 minutes after induction and every 15 minutes until the end of the operation and in recovery. The surgeon's overall satisfaction with the amount of bleeding during the operation at the surgical site is also assessed and recorded. Dose of narcotics. Timepoint: During the operation. Method of measurement: View and record. Surgeon satisfaction with bleeding during surgery. Timepoint: During the operation. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2021-09-01 Ethics committee of Tehran University of Medical Sciences Corner of Ghods Street, Keshavarz Boulevard,the headquarters of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)