Patients scheduled to undergo noncardiac surgery with invasive arterial pressure monitoring
Conditions
Interventions
The anesthetic induction agent will be randomly assigned.
(1) Study drug: Remimazolam
The dose will be administered continuously at a rate of 6 mg/kg/h. After loss of consciousness is confirmed, the r
Sponsors
Suda Yasuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 30 to 79 years at the time of obtaining consent 2. Patients who have given written consent to participate in this study 3. Patients undergoing non-cardiac surgery 4. Patients scheduled to undergo invasive arterial pressure monitoring 5. Patients with American Society of Anesthesiologists Physical Status of I or II
Exclusion criteria
Exclusion criteria: 1. Patients in whom the entire left ventricle could not be observed from the apex of the heart in the preoperative transthoracic echocardiogram 2. Patients who have not had a preoperative transthoracic echocardiogram 3. Patients with moderate or severe valvular disease 4. Patients with a history of myocardial infarction 5. Patients with a history of dilated cardiomyopathy 6. Patients with abnormal left ventricular wall motion in the preoperative transthoracic echocardiogram 7. Patients with chronic obstructive pulmonary disease 8. Patients with barrel chest seen on chest X-ray before surgery 9. Patients who require rapid sequence induction of anesthesia 10. Patients with preoperative hemodynamic instability 11. Hypertensive patients with a first systolic blood pressure of 140/90 mmHg or higher measured in the hospital ward after admission 12. Patients with congenital heart disease 13. Patients allergic to the study drug 14. Patients with a body mass index of less than 18 or more than 35 15. Patients with cirrhosis 16. Patients who are regularly taking benzodiazepine sedatives, sleep medication, or seizure medication before surgery 17. Patients in who an increase in pulmonary artery pressure was predicted by preoperative echocardiography 18. Patients with constrictive pericarditis on preoperative echocardiography 19. Patients with a left ventricular ejection fraction of less than 50% on preoperative echocardiography 20. Patients with a left ventricular aneurysm on preoperative examination 21. Patients with atrial fibrillation 22. Patients deemed unsuitable by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in 'left ventricular end-diastolic volume', 'effective arterial elastance', and 'end-systolic pressure-volume relationship' before and after the administration of the test anesthetic will be measured. A test will be conducted to determine whether there is a significant difference in the amount of change between the two groups, and a 95% confidence interval will be calculated. If the data are normally distributed, a non-paired t-test will be conducted, and if they are not normally distributed, a Mann-Whitney U test will be conducted. If necessary, we will also conduct multivariate analysis that takes into account missing values and allocation factors. This study is a preliminary study, and the main purpose is to estimate the factors that have the greatest impact on circulatory dynamics and to determine the sample size for the next study. Therefore, the main evaluation items, effect size, and sample size for the next study will be determined based on the results obtained. The following methods will be used to measure each item. 1: Left ventricular end-diastolic volume: The volume of the left ventricle will be measured using three-dimensional echocardiography via a transthoracic echocardiogram. 2: Effective arterial elastance: This will be calculated using data obtained from a transthoracic echocardiogram and invasive arterial pressure measurement. 3: End-systolic pressure-volume relationship: This will be calculated using data obtained from a transthoracic echocardiogram and invasive arterial pressure measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following items will be measured for changes before and after the administration of the study drugs. 1: Blood pressure information, 2: Heart rate, 3: Stroke volume, 4: Cardiac output (cardiac index), 5: Left ventricular ejection fraction, 6: Left ventricular volume, 7: Body vascular resistance, 8: Time to loss of consciousness, 9: Bispectral Index after administration of anesthetic A test will be conducted to determine whether there is a significant difference between the two groups. If the data are normally distributed, a non-paired t-test will be used, and if they are not normally distributed, a Mann-Whitney U test will be used to calculate a 95% confidence interval. If necessary, missing values will be supplemented and multivariate analysis will be conducted taking into account the allocation factors. 10: The amount of loss of consciousness for each anesthetic will be investigated. The correlation between changes in blood pressure and 11: preload, 12: afterload, and 13: contractility will be investigated. | — |
Contacts
Public ContactYasuhiro Suda
Asahikawa Medical University
Outcome results
None listed