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.

Prevention of cognitive disorders using cerebral oximetry in patients undergoing heart surgery requiring extracorporeal circulation

A concealed, randomized,three way blinded, controlled clinical trial with a parallel group design of 100 patients.For randomization, the method of random allocation law and the website www.randomization.com are used, and for allocation concealment, sealed envelopes are used.

After selection and obtaining consent from the participant, randomization and concealment are done. There are 100 participants in total, and there are equal numbers in two intervention and control groups. Subjects will be tested for mental function before the operation and eight days after the operation. Cerebral oximetry is used in the intervention group and not used in the control group. The study is three-way blind: the participant does not know which group he is in, the researcher does not know which group the person being tested is in, the evaluators are analyzing the test results and does not know which group they are in .

A candidate for heart surgery requiring extracorporeal circulation, age under 65 and No carotid stenosis. Not having, kidney failure, history of mental disorders, addiction and drug use, head trauma and cerebrovascular accidents. Being literate in reading and writing.

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. In the control group, cerebral oximetry is not used and changes in blood pressure and blood gases are adjusted according to standard values.

Mental disorder after heart surgery requiring extracorporeal circulation

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 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.

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

Beginning of the access period 07/01/1401

Data access is possible for researchers working in academic and practical institutions in the field of medicine.

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.

Morteza Mazaher hesari cell: 00989904944866

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.