Patients undergoing general anesthesia in the operation room
Conditions
Interventions
Remimazolam is used as the induction agent during anesthesia, and hemodynamic parameters are monitored.
Propofol is used as the drug for induction of anesthesia, and hemodynamic parameters are monitor
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 years or older who, after receiving adequate explanation regarding participation in this study, provided written consent based on full understanding and of their own free will 2.Patients with mild to moderate heart disease 3.Patients at risk of massive bleeding The above patient groups meet the criteria for HPI (Hypotension Prediction Index) insurance coverage. In these patients, induction of anesthesia may cause circulatory fluctuations, potentially leading to hypotension or bradycardia. This study aims to evaluate whether remimazolam use contributes to circulatory stabilization in this patient population.
Exclusion criteria
Exclusion criteria: 1.Severe heart disease (NYHA Class 3-4 heart failure, EF <30%, Rest angina or acute myocardial infarction within 3 months, uncontrollable severe arrhythmia, severe valvular disease such as aortic stenosis (AVA < 1.0 cm2, mean pressure gradient > 40 mmHg) or severe mitral regurgitation causing markedly impaired cardiac function, severe pulmonary hypertension (e.g., mean pulmonary artery pressure > 45 mmHg, cases with high risk of right heart failure) 2.Patients with allergies to the induction agent 3.Patients undergoing hemodialysis therapy 4.Patients with severe hepatic impairment (Child-Pugh class C or higher) 5.Patients with atrial fibrillation or atrial/ventricular premature contractions 6.Obese patients with BMI > 35 7.Patients in shock, e.g., mean blood pressure < 70 mmHg prior to anesthesia induction 8.Patients with failed initial oral endotracheal intubation 9.Cases where patient consent cannot be obtained despite family/proxy consent 10.Other patients deemed unsuitable for inclusion by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Hypotension Incidence Between Groups from Anesthesia Induction to Pre-Surgical Intervention Hypotension is defined as a decrease in systolic blood pressure of 20% or more from baseline values, or a mean arterial pressure below 65 mmHg. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Comparison of the amount and frequency of vasopressor use, fluid volume administered, frequency and severity of hypotension, and duration (area under threshold curve and time-weighted average) during induction in both groups 2.Comparison of BP, HR, CVV, SVI, and CI in each group relative to baseline values (pre-induction) | — |
Countries
Japan
Contacts
Public ContactTomoki Fukuda
Adachi Medical Center, Tokyo Women's Medical University Department of Anesthesiology
Outcome results
None listed