]>
IRCT20151003024317N11 IRCT 2020-07-11 Iran University of Medical Sciences The Effect of Target Control Infusion (TCI) on the Creatine Level of Patients Comparison of the effect of target control injection (TCI) of anesthetic with conventional method on creatinine level of patients with renal impairment in open heart surgery 2020-07-20 anticipated 66 Complete https://irct.ir/trial/48271 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to tree groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 6. In each block, 2 individuals will be in intervention group 1, 2 individuals will be in intervention group 2 and 2 will be in control group. A total of 11 blocks will be considered for the study, Blinding description: Surgeons and patients will be kept blind and unaware of the type of anesthesia. Patients will be aware that they will be randomly assigned to one of three treatment groups, but will be unaware of which treatment will be provided in that group. Patients will be assigned to one of three groups using random number tables. The surgeon also knows that patients will be anesthetized in three different ways, but will not know which procedure will be performed for each patient. The data collection officer, analyst, outcome assessor and data safety and Data Safety and Monitoring Committee will collect and analyze information based on groups 1, 2 and 3 and will not be aware of the type of treatment provided in the groups. They will be kept blind. 3 Renal impairment in open heart surgery. Intervention 1: First intervention group: For anesthesia of patients by targeted controlled injection, Remy Fentanyl with a dose of 0.5-1 μ/kg (manufacturer: NORMON,SA(spain)), proponol with a dose of 2 - 2.5 mg/kg (manufacturer: BRUN/B) and Cis Atracurium (Manufacturer: Behin Tamin Rosa Mod Co.) at a dose of 0.15-0.2 mg/kg will be injected. Then, depending on the depth of anesthesia, the drug will injected and whenever the number of BIS reaches between 40 and 60, the patient will intubated and in order to maintenance anesthesia, proponol with a dose of 2-3 μ/ml in patients over 50 years or 3-4 μ/ml in Patients under 50 years, Remy Fentanyl with a dose of 3-6 ng/ml in patients over 50 years and 5-8 ng/ml in patients less than 50 years and finally Cis Atracurium with a dose of 3 μ/ kg/min will be prescribed with TCI technique. Intervention 2: Second intervention group: for anesthesia of patients from Midazolam with a dose of 0.2 - 0.4 mg/kg (manufactured by Exir Company), Fentanyl with a dose of 2-20 μg/kg (manufactured by Caspian Tamin Rasht Factory) and Atracurium with a dose of 0.005 - 0.01 mg/kg/min (manufactured by Abu Reihan Company) Will be infused continuously. Intervention 3: Control group: For patients undergoing conventional anesthesia, Remy Fentanyl with a dose of 0.5-1 μ/kg (manufacturer: NORMON,SA(spain)), proponol with a dose of 2 - 2.5 mg/kg (manufacturer: BRUN/B) and Cis Atracurium (Manufacturer: Behin Tamin Rosa Mod Co.) at a dose of 0.15-0.2 mg/kg will be injected. Then, depending on the depth of anesthesia, the drug will injected and whenever the number of BIS reaches between 40 and 60, the patient will intubated and in order to maintenance anesthesia, proponol with a dose of 2-3 μ/ml in patients over 50 years or 3-4 μ/ml in Patients under 50 years, Remy Fentanyl with a dose of 3-6 ng/ml in patients over 50 years and 5-8 ng/ml in patients less than 50 years and finally Cis Atracurium with a dose of 3 μ/ kg/min will be injected with a regular pump.
public Mohsen Ziyaei Fard
Rajaie Cardiovascular Medical and Research Center, Next to Mellat Park, Vali-e-Asr St.
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 mziyaeifard@yahoo.com Iran University of Medical Sciences scientific Mohsen Ziyaei Fard
Rajaie Cardiovascular Medical and Research Center, Next to Mellat Park, Vali-e-Asr St.
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 mziyaeifard@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for open heart surgery who have creatinine greater than 1.5 mg / dl Patients over 18 years old 18 years 75 years Both Patients over 70 years Pregnancy I97.1 Other functional disturbances following cardiac surgery Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: For anesthesia of patients by targeted controlled injection, Remy Fentanyl with a dose of 0.5-1 μ/kg (manufacturer: NORMON,SA(spain)), proponol with a dose of 2 - 2.5 mg/kg (manufacturer: BRUN/B) and Cis Atracurium (Manufacturer: Behin Tamin Rosa Mod Co.) at a dose of 0.15-0.2 mg/kg will be injected. Then, depending on the depth of anesthesia, the drug will injected and whenever the number of BIS reaches between 40 and 60, the patient will intubated and in order to maintenance anesthesia, proponol with a dose of 2-3 μ/ml in patients over 50 years or 3-4 μ/ml in Patients under 50 years, Remy Fentanyl with a dose of 3-6 ng/ml in patients over 50 years and 5-8 ng/ml in patients less than 50 years and finally Cis Atracurium with a dose of 3 μ/ kg/min will be prescribed with TCI technique. Second intervention group: for anesthesia of patients from Midazolam with a dose of 0.2 - 0.4 mg/kg (manufactured by Exir Company), Fentanyl with a dose of 2-20 μg/kg (manufactured by Caspian Tamin Rasht Factory) and Atracurium with a dose of 0.005 - 0.01 mg/kg/min (manufactured by Abu Reihan Company) Will be infused continuously. Control group: For patients undergoing conventional anesthesia, Remy Fentanyl with a dose of 0.5-1 μ/kg (manufacturer: NORMON,SA(spain)), proponol with a dose of 2 - 2.5 mg/kg (manufacturer: BRUN/B) and Cis Atracurium (Manufacturer: Behin Tamin Rosa Mod Co.) at a dose of 0.15-0.2 mg/kg will be injected. Then, depending on the depth of anesthesia, the drug will injected and whenever the number of BIS reaches between 40 and 60, the patient will intubated and in order to maintenance anesthesia, proponol with a dose of 2-3 μ/ml in patients over 50 years or 3-4 μ/ml in Patients under 50 years, Remy Fentanyl with a dose of 3-6 ng/ml in patients over 50 years and 5-8 ng/ml in patients less than 50 years and finally Cis Atracurium with a dose of 3 μ/ kg/min will be injected with a regular pump. Total dose of anesthesia. Timepoint: After surgery. Method of measurement: Based on patient records. Creatinine levels. Timepoint: During surgery, After surgery, 24 hours after surgery. Method of measurement: Based on patient records. Duration of hospitalization in the ICU. Timepoint: During patient discharge. Method of measurement: Based on patient records. Iran University of Medical Sciences Approved 2020-05-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)