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IRCT20161022030421N2 IRCT 2018-03-02 Bagheiat-allah University of Medical Sciences comparing post cardiac surgery neurological side effects in interventional group for maintain regional cerebral O2 saturation more than 50% versus non interventional group Clinical trial comparing post cardiac surgery neurological side effects in interventional group for maintain regional cerebral O2 saturation more than 50% versus non interventional group 2017-12-23 anticipated 200 Complete https://irct.ir/trial/28351 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization was stratified using a random table number. N/A neurological side effects after cardiac surgery. Intervention 1: Interventional group:A group that monitoring of Cerebral oximetry (rScO2) will be performed .interventions were performed to maintain rScO2 at, or above the baseline value, including increased Paco2 to 45 mmHg, increases blood pressure by increasing blood flow pump, use of inotropes, lower oxygen consumption of the brain using barbiturates and re positioning the patient’s head. Intervention 2: Control group: A group that is routinely monitored and there is no intervention for them. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 1 months after publication To whom: people working in academic institutions Conditions: for meta analysis Where to obtain: from Email How to obtain: By sending a request to the university Vice-Dean for Research and obtaining a license Comments:
public Marzieh Lak
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 212449013 marziehlak@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Marzieh Lak
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 212449013 marziehlak@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) patients who underwent a cardiac surgery with cardiopulmonary bypass pump (CPB pump). no limit no limit Both Patients with history of psychological disorder patients who were taking psychiatric drugs Prevention Prevention Interventional group:A group that monitoring of Cerebral oximetry (rScO2) will be performed .interventions were performed to maintain rScO2 at, or above the baseline value, including increased Paco2 to 45 mmHg, increases blood pressure by increasing blood flow pump, use of inotropes, lower oxygen consumption of the brain using barbiturates and re positioning the patient’s head. Control group: A group that is routinely monitored and there is no intervention for them Neurological side effects. Timepoint: Up to 72 hours after surgery. Method of measurement: Interview and neurological examination. Bagheiat-allah University of Medical Sciences Approved 2017-12-17 Ethics committee of baqiyatallah university of medical sciences Baqiyatallah university of medical science, Mollasadra Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)