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
The study of the effect of the use of Npinephrine, Norepinephrine and Phenylephrine drugs during cardiopulmonary bypass on brain oxygenation in patients undergoing open heart surgery
Design
90 participans for open heart surgery candidates are randomly divided to three groups. The clinical trial will consist of three parallel and two-blind groups.
Settings and conduct
This study will be conducted in the operating room and ICU at Shahid Rajaee Heart Center and patients will be unaware of the type of medication used.
Participants/Inclusion and exclusion criteria
Inclusion criterria: Patient satisfaction to participate in the study, patients undergoing elective open-heart surgery, patients over 18 years of age, no history of transient cerebral ischemic disease or stroke, lack of stenosis of the carotid arteries of more than 70%, or no clear stenosis, No previous history of previous cardiac surgery, no diabetes mellitus (with the opinion of an internal medicine specialist), and uncontrolled blood pressure (with the opinion of the cardiologist). Exclusion criteria: cardiac arrest before starting of by-pass, no need to prescribe inotropic drugs during Pulmonary artery bypass surgery
Intervention groups
Based on the random categorization of patients in the three groups under the interventionduring the bypass to maintain blood pressure in patients above 60 mmHg after increasing the flow, if necessary,Norepinephrine drugs of 5 to 10 micrograms and Epinephrine 5 to 10 micrograms and Phenylefrin 40 to 60 micrograms will be used.
Main outcome variables
Brain oxygen saturation and arterial blood gases and hemoglobin and hematocrit will be recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043582N1
Registration date:2019-06-18, 1398/03/28
Registration timing:prospective
Last update:2019-06-18, 1398/03/28
Update count:0
Registration date
2019-06-18, 1398/03/28
Registrant information
Name
reza rostami
Name of organization / entity
Rajaei heart center
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 0401
Email address
rostami_reza755@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-20, 1398/05/29
Expected recruitment end date
2019-10-21, 1398/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison of the use of Epinephrine, Norepinephrine and Phenylephrine drugs during cardiopulmonary bypass on brain oxygenation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
Heart arrest before starting cardiac bypass
No need to prescribe inotropic drugs during surgery
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethict commitee of Shahid Rajaei Cardiovascular Medical and Research heart center
120, 150 and 180 seconds after injections of inotropic drugs during cardiopulmonary bypass.
Method of measurement
Monitoring of cerebral oxygen saturation
2
Description
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
3
Description
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
4
Description
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
5
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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).
Category
Treatment - Drugs
2
Description
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).
Category
Treatment - Drugs
3
Description
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).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operation room of Shahid Rajaee Cardiovascular Center Tehran
Full name of responsible person
Reza Rostami
Street address
Shahid Rajaee Cardiovascular Center,Valiasr street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
rostami_reza755@yahoo.com
Web page address
http://www.rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaee Cardiovascular Center Tehran
Full name of responsible person
Dr Mohsen Ziyaeifard
Street address
Shahid Rajaee Cardiovascular Center ,Valiasr street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
mziyaeifard@yahoo.com
Web page address
http://rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?