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IRCT20191016045133N1 IRCT 2019-11-08 Ahvaz University of Medical Sciences Investigating the Pulmonary Function Parameters following Coronary Artery Bypass Surgery in Patients with General Anesthesia and General Anesthesia with Spinal Anesthesia Investigating the Pulmonary Function Parameters following Coronary Artery Bypass Surgery in Patients with General Anesthesia and General Anesthesia with Spinal Anesthesia 2019-09-23 anticipated 60 Complete https://irct.ir/trial/43177 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group and the odd numbers for the control group are considered. According to the number of patients, they are randomly assigned to one of the intervention or control groups, Blinding description: Participants are informed about the purpose and method of study. After receiving informed consent, they are blinded to the study groups to unify patients in terms of their induction sense. Researchers responsible for data collection and analyses are also blind to the groups allocation. 3 coronary artery bypass. Intervention 1: Control group: General anesthesia is administered intravenously with midazolam 2 mg, fentanyl 3 µg/kg, lidocaine (20%) 1.5 mg/kg, thiopental sodium 3 mg/kg and atracurium 0.6 mg/kg. Intervention 2: Intervention group: Before induction of general anesthesia, spinal anesthesia is performed with intrathecal injection of 20 mg bupivacaine 0.5% on sitting position in L3-L4 midline space with needle gauge 25. 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 more information
public Sina Dehdashtiha
Imam Khomeini Hospital, Azadegan Ave.
Ahvaz Iran (Islamic Republic of) 6135715794 009861329235893 Sina.dehdashti@gmail.com Ahvaz University of Medical Sciences scientific Kamaladin Tabatabaei
Imam Khomeini Hospital, Azadegan Ave.
Ahvaz Iran (Islamic Republic of) 6135715794 009861322235292 KT1343@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Male patients who are candidates for coronary artery bypass surgery Age group 40 to 65 years 40 years 65 years Male History of cardiac surgery History of coagulopathy Antiplatelet consumption before surgery Severe lumbar deformity or BMI greater than 35 Contraindication of neuro-axial block Systemic or local infection Treatment - Drugs Treatment - Drugs Control group: General anesthesia is administered intravenously with midazolam 2 mg, fentanyl 3 µg/kg, lidocaine (20%) 1.5 mg/kg, thiopental sodium 3 mg/kg and atracurium 0.6 mg/kg. Intervention group: Before induction of general anesthesia, spinal anesthesia is performed with intrathecal injection of 20 mg bupivacaine 0.5% on sitting position in L3-L4 midline space with needle gauge 25. Tidal Volume (TV). Timepoint: 1, 2, 4, 6 and 12 hours after extubation. Method of measurement: Spirometry. Vital Capacity (VC). Timepoint: 1, 2, 4, 6 and 12 hours after extubation. Method of measurement: The sum of Tidal Volume (TV) and Inspiratory Reserve Volume (I.R.V) and Expiratory Reserve Volume (E.R.V) (Using spirometry). The partial pressure of carbon dioxide (PaCO2). Timepoint: 1, 2, 4, 6 and 12 hours after extubation. Method of measurement: Blood test. The partial pressure of oxygen (PaO2). Timepoint: 1, 2, 4, 6 and 12 hours after extubation. Method of measurement: Blood test. Blood PH. Timepoint: 1, 2, 4, 6 and 12 hours after extubation. Method of measurement: Blood test. Ahvaz University of Medical Sciences Approved 2019-04-13 Ethics committee of Ahvaz University of Medical Sciences Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)