Hemodynamic Instability
Conditions
Keywords
propofol, remimazolam
Brief summary
Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.
Interventions
DRUGRemimazolam
Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)
DRUGPropofol
Propofol: target controlled infusion: 2-3mcg/mL
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status: 1-3 * age: 19-80 years * patients who are scheduled to undergo a major spine surgery in the prone position
Exclusion criteria
* patients who refuse to participate * body mass index: \<15kg/m2 or \>35kg/m2 * patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease * patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication * allergic to propofol and midazolam * patients who are judged unsuitable to participate in the study for other reasons by medical staffs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of hypotensive episode per patient | for one hour after turning the patients to the prone position | SAP \< baseline SBP \* 80% or 90mmHg // MAP \< baseline MAP \* 80% or 65mmHg |
| the number of severe hypotensive episode per patient | for one hour after turning the patients to the prone position | SAP \< baseline SBP \* 70% or 80mmHg // MAP \< baseline MAP \* 70% or 55mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| heart rate | for one hour after turning the patients to the prone position | heart rate from EKG |
| Total opioid consumption | for one hour after turning the patients to the prone position | amount of total opioid administered |
| cardiac index | for one hour after turning the patients to the prone position | cardiac index from Flotrac |
| stroke volume | for one hour after turning the patients to the prone position | stroke volume from Flotrac |
| stroke volume variation | for one hour after turning the patients to the prone position | stroke volume variation from Flotrac |
| cardiac output | for one hour after turning the patients to the prone position | cardiac output from Flotrac |
| pleth variability index | for one hour after turning the patients to the prone position | pleth variability index |
Countries
South Korea
Outcome results
None listed