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IRCT20220427054671N1 IRCT 2022-07-11 Mashhad University of Medical Sciences Evaluation of using cerebral oximetry in decreasion of brain disorder in patient undergoing on pump cardiac surgery Evaluation of using cerebral oximetry in decreasion of mental status disorder in patient undergoing cardiac surgery requiring extracorporeal circulation . by using mini menal status examination in pre and post operaion. 2022-07-09 anticipated 100 Complete https://irct.ir/trial/63259 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Allocation law method Randomization is the simplest method of limited randomization. This method represents a large block for the entire sample volume. This means that the balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, first a volume Determined the overall sample and then randomly assigned a group of them to group A and the rest to group B. For example, in a study with a sample size of 100 people, 50 balls for the intervention group A and 50 balls for the intervention group B inside a lottery container then the balls are randomly removed from the container without replacement and the created sequence is recorded . allocation concealment method: using non-transparent sealed envelopes with random sequence, Blinding description: Blinding of the participants: After explaining the study and obtaining consent from the patient to participate in the study, he does not know which group he will be placed in. Blinding of the researcher: the researcher does not know which group the participant is in during the test before and after the operation. Blinding of the outcome assessor: the person who evaluates the occurrence or non-occurrence of the outcome does not know which group the information belongs to during the evaluation. N/A Post cardiac operation cognitive disorders. Intervention group: In the intervention group, during extracorporeal blood circulation, cerebral oximetry is used, and by using this tool, changes in blood pressure and blood gases are also applied according to the result of cerebral oximetry. Control group: Cerebral oximetry is not used in the control group and changes in blood pressure and blood gases are adjusted according to standard values. Yes - There is a plan to make this available What will be shared: The main result of the study and the changes observed in the parameters being measured in the intervention group and the answer to the main question of the study When: Beginning of the access period 07/01/1401 To whom: Data access is possible for researchers working in academic and practical institutions in the field of medicine. Conditions: The request for statistical and psychological analysis is accepted by people who are active in this field, and people who are active in the field of heart surgery and a request for improvement in obtaining the result that is possible with further investigation and broader analysis of the data can also have access to the data. Where to obtain: Morteza Mazaher hesari cell: 00989904944866 How to obtain: First, contact the person who registers and conducts the study, and after explaining the reason for the need for data and documentation and consulting with the supervisor, the information will be provided. Comments:
public Mazaher Hesari Morteza
No11, madani Ave,Moradbak Alley , narmak
Tehran Iran (Islamic Republic of) 1643665341 +98 21 7728 8396 mhmori124@gmail.com Mashhad University of Medical Sciences scientific Morteza Mazaher hesari
No11,moradbak alley,madani ave, tehran citi
Tehran Iran (Islamic Republic of) 1643665341 +98 21 7650 4028 Mhmori124@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) patient whom candidated for cardiac surgery requiring extra corporeal circulation . less than 65 years old absence of carotid stenosis in patients over 60 years old. not having a history of benzodiazepines and opium addiction before the operation . not having a history of mental disorders . no histiry of kidney disorder and anemia and history of blood transfusion . not having a history of trauma and cerebrovascular accidents, including stroke . having literate in reading and writing . 18 years 65 years Both Prevention Intervention group: In the intervention group, during extracorporeal blood circulation, cerebral oximetry is used, and by using this tool, changes in blood pressure and blood gases are also applied according to the result of cerebral oximetry. Control group: Cerebral oximetry is not used in the control group and changes in blood pressure and blood gases are adjusted according to standard values Mini mental status test score. Timepoint: The day before the operation and at the time of discharge from the hospital or eight days after the operation. Method of measurement: Mini mental status test. NO. Timepoint: NO. Method of measurement: NO. Mashhad University of Medical Sciences Approved 2022-02-15 Ethics committee of Mashhad University of Medical Sciences No.11 , sh madani Ave.,Moradbak Alley., narmak Tehran Tehran Iran (Islamic Republic of)