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IRCT20190514043582N1 IRCT 2019-06-18 Shahid Rajaee Cardiovascular Center Tehran Comparison of the use of Epinephrine, Norepinephrine and Phenylephrine drugs during cardiopulmonary bypass on brain oxygenation The study of the effect of the use of Epinephrine, Norepinephrine and Phenylephrine drugs during cardiopulmonary bypass on brain oxygenation in patients undergoing open heart surgery 2019-08-20 anticipated 90 Complete https://irct.ir/trial/39623 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization method Will be performed as a six-point random block, and patients will be assigned to three groups according to the randomization list, Blinding description: in this study,direction blind of the method six blocks are used. And practical none of the patients are aware of the grouping of drugs. In the beginning of the surgery, one of the three inotropic drugs was studied, without label and only on the basis of the randomization method at the disposal of the perfusionist who is responsible for the bypass.and he did not know the type of drug during the bypass pump. If the median arterial pressure drops to less than 50 mmHg, it will use a medication of one milliliter. As well as a person who records patient information does not have any sort of information grouping. 1-2 hypotension. Intervention 1: Intervention group: At the entrance to the operating room, patients will receive oxygen from the nasal cannula at 2 liters per minute. The ECG and average arterial blood pressure monitors and the cerebral-oxymeter system sensors will be connected to the patients before the start of anesthesia to determine the saturation of the brain oxygenation. Based on the random categorization of patients in the three groups during CPB to maintain and maintain the blood pressure of the patients Above 60 mmHg after increasing flow, if needed, a norepinephrine dose of 5 to 10 micrograms will be used. Arterial blood pressure, arterial oxygen saturation, and ScO2 will be recorded for each patient before the starting of anesthesia and the bypass. During the CPB period, the oxygen saturation saturation of 120, 150 and 180 seconds after injection of Inotrope drugs will be measured. The mean of arterial blood pressure, PaO2, body temperature of the patient, ScO2, will be displayed and recorded during the CPB period through the monitor. The mean arterial blood pressure and the measurement of the mean arterial pressure It will be done. ScO2 is also measured and displayed by brain oximetric monitors (INVOS, INVOS Somanetics, Troy, MI, USA). Intervention 2: Intervention group: At the entrance to the operating room, patients will receive oxygen from the nasal cannula at 2 liters per minute. The ECG and average arterial blood pressure monitors and the cerebral-oxymeter system sensors will be connected to the patients before the start of anesthesia to determine the saturation of the brain oxygenation. Based on the random categorization of patients in the three groups during CPB to maintain and maintain the blood pressure of the patients Above 60 mmHg after increasing flow, if needed, a Epinephrine dose of 5 to 10 micrograms will be used. Arterial blood pressure, arterial oxygen saturation, and ScO2 will be recorded for each patient before the starting of anesthesia and the bypass. During the CPB period, the oxygen saturation saturation of 120, 150 and 180 seconds after injection of Inotrope drugs will be measured. The mean of arterial blood pressure, PaO2, body temperature of the patient, ScO2, will be displayed and recorded during the CPB period through the monitor. The mean arterial blood pressure and the measurement of the mean arterial pressure It will be done. ScO2 is also measured and displayed by brain oximetric monitors (INVOS, INVOS Somanetics, Troy, MI, USA). Intervention 3: Intervention group: At the entrance to the operating room, patients will receive oxygen from the nasal cannula at 2 liters per minute. The ECG and average arterial blood pressure monitors and the cerebral-oxymeter system sensors will be connected to the patients before the start of anesthesia to determine the saturation of the brain oxygenation. Based on the random categorization of patients in the three groups during CPB to maintain and maintain the blood pressure of the patients Above 60 mmHg after increasing flow, if needed, a Phenylephrine dose of 5 to 10 micrograms will be used. Arterial blood pressure, arterial oxygen saturation, and ScO2 will be recorded for each patient before the starting of anesthesia and the bypass. During the CPB period, the oxygen saturation saturation of 120, 150 and 180 seconds after injection of Inotrope drugs will be measured. The mean of arterial blood pressure, PaO2, body temperature of the patient, ScO2, will be displayed and recorded during the CPB period through the monitor. The mean arterial blood pressure and the measurement of the mean arterial pressure It will be done. ScO2 is also measured and displayed by brain oximetric monitors (INVOS, INVOS Somanetics, Troy, MI, USA). No - There is not a plan to make this available Justification or reason for not sharing IPD is Privacy Patients
public Reza Rostami
Shahid Rajaee Cardiovascular Center,Valiasr street,Ayatollah Hashemi Highway,Tehran,iran
Tehran Iran (Islamic Republic of) 1444635458 +98 21 6653 9401 rostami_reza755@yahoo.com Shahid Rajaee Cardiovascular heart center scientific Reza Rostami
Shahid Rajaee Cardiovascular Center,valiasr street,Ayatollah Hashemi Highway,Tehran,iran
Tehran Iran (Islamic Republic of) 19956114331 +98 21 2392 2454 rostami_reza755@yahoo.com shahid rajai cardiovascular center Iran (Islamic Republic of) Patient satisfaction to participate in the study Patients undergoing elective open-heart surgery (Coronary artery bypass graft surgery and heart valve surgery) Patients older than 18 years No history of transient cerebral ischemic disease or stroke No history of narrowing of the carotid arteries by more than 70% or no clear stenosis No history of previous cardiac surgery Not having of uncontrolled diabetes (with the opinion of an internal specialist) or the absence of uncontrolled blood pressure (with the opinion of the cardiologist) 18 years no limit Both Heart arrest before starting cardiac bypass No need to prescribe inotropic drugs during surgery I95.8 Other hypotension Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: At the entrance to the operating room, patients will receive oxygen from the nasal cannula at 2 liters per minute. The ECG and average arterial blood pressure monitors and the cerebral-oxymeter system sensors will be connected to the patients before the start of anesthesia to determine the saturation of the brain oxygenation. Based on the random categorization of patients in the three groups during CPB to maintain and maintain the blood pressure of the patients Above 60 mmHg after increasing flow, if needed, a norepinephrine dose of 5 to 10 micrograms will be used. Arterial blood pressure, arterial oxygen saturation, and ScO2 will be recorded for each patient before the starting of anesthesia and the bypass. During the CPB period, the oxygen saturation saturation of 120, 150 and 180 seconds after injection of Inotrope drugs will be measured. The mean of arterial blood pressure, PaO2, body temperature of the patient, ScO2, will be displayed and recorded during the CPB period through the monitor. The mean arterial blood pressure and the measurement of the mean arterial pressure It will be done. ScO2 is also measured and displayed by brain oximetric monitors (INVOS, INVOS Somanetics, Troy, MI, USA). Intervention group: At the entrance to the operating room, patients will receive oxygen from the nasal cannula at 2 liters per minute. The ECG and average arterial blood pressure monitors and the cerebral-oxymeter system sensors will be connected to the patients before the start of anesthesia to determine the saturation of the brain oxygenation. Based on the random categorization of patients in the three groups during CPB to maintain and maintain the blood pressure of the patients Above 60 mmHg after increasing flow, if needed, a Epinephrine dose of 5 to 10 micrograms will be used. Arterial blood pressure, arterial oxygen saturation, and ScO2 will be recorded for each patient before the starting of anesthesia and the bypass. During the CPB period, the oxygen saturation saturation of 120, 150 and 180 seconds after injection of Inotrope drugs will be measured. The mean of arterial blood pressure, PaO2, body temperature of the patient, ScO2, will be displayed and recorded during the CPB period through the monitor. The mean arterial blood pressure and the measurement of the mean arterial pressure It will be done. ScO2 is also measured and displayed by brain oximetric monitors (INVOS, INVOS Somanetics, Troy, MI, USA). Intervention group: At the entrance to the operating room, patients will receive oxygen from the nasal cannula at 2 liters per minute. The ECG and average arterial blood pressure monitors and the cerebral-oxymeter system sensors will be connected to the patients before the start of anesthesia to determine the saturation of the brain oxygenation. Based on the random categorization of patients in the three groups during CPB to maintain and maintain the blood pressure of the patients Above 60 mmHg after increasing flow, if needed, a Phenylephrine dose of 5 to 10 micrograms will be used. Arterial blood pressure, arterial oxygen saturation, and ScO2 will be recorded for each patient before the starting of anesthesia and the bypass. During the CPB period, the oxygen saturation saturation of 120, 150 and 180 seconds after injection of Inotrope drugs will be measured. The mean of arterial blood pressure, PaO2, body temperature of the patient, ScO2, will be displayed and recorded during the CPB period through the monitor. The mean arterial blood pressure and the measurement of the mean arterial pressure It will be done. ScO2 is also measured and displayed by brain oximetric monitors (INVOS, INVOS Somanetics, Troy, MI, USA). Brain Oxygenation. Timepoint: 120, 150 and 180 seconds after injections of inotropic drugs during cardiopulmonary bypass. Method of measurement: Monitoring of cerebral oxygen saturation. Blood lactate level. Timepoint: Before the starting of cardiopulmonary bypass and during anesthesia,during cardiopulmonary bypasses at certain intervals and after the end of the cardiopulmonary artery bypass. Method of measurement: Arterial blood sample and arterial gas analyzer. PH Level. Timepoint: Before starting of cardiopulmonary bypass and during anesthesia,During cardiopulmonary bypasses at certain intervals and after the end of the cardiopulmonary artery bypass. Method of measurement: Arterial blood sample and arterial gas analyzer. Duration of mechanical ventilation after surgery in patients. Timepoint: After surgery and in the intensive care unit. Method of measurement: The length of time the patient is in the intensive care unit is connected to the ventilator. The duration of return of normal heart rhythm and the need for defibrillator and the need to use pacemakers. Timepoint: After surgery and in the intensive care unit. Method of measurement: Within 48 hours after the end of the pulmonary bypass. The rate of Use of Epinephrine, Norepinephrine and Phenylephrine for Maintaining Mean Arterial Pressure in the Range of 60 to 80 mmHg. Timepoint: At a time when the patient's blood pressure falls below 60 mm Hg during cardiopulmonary bypass. Method of measurement: Observation. Shahid Rajaee Cardiovascular Center Tehran Approved 2019-04-27 Ethict commitee of Shahid Rajaei Cardiovascular Medical and Research heart center Shahid Rajaee Cardiovascular Center,valiasr street,Ayatollah Hashemi Highway,Tehran,iran Tehran Tehran Iran (Islamic Republic of)