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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam group | Experimental | patients who receive remimazolam-remifentanil based total intravenous anesthesia |
|
| propofol group | Active Comparator | patients who receive propofol-remifentanil based total intravenous anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of hypotensive episode per patient | SAP < baseline SBP * 80% or 90mmHg // MAP < baseline MAP * 80% or 65mmHg | for one hour after turning the patients to the prone position |
| the number of severe hypotensive episode per patient | SAP < baseline SBP * 70% or 80mmHg // MAP < baseline MAP * 70% or 55mmHg | for one hour after turning the patients to the prone position |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac index | cardiac index from Flotrac | for one hour after turning the patients to the prone position |
| pleth variability index | pleth variability index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Propofol: target controlled infusion: 2-3mcg/mL |
|
| for one hour after turning the patients to the prone position |
| heart rate | heart rate from EKG | for one hour after turning the patients to the prone position |
| Total opioid consumption | amount of total opioid administered | for one hour after turning the patients to the prone position |
| cardiac output | cardiac output from Flotrac | for one hour after turning the patients to the prone position |
| stroke volume | stroke volume from Flotrac | for one hour after turning the patients to the prone position |
| stroke volume variation | stroke volume variation from Flotrac | for one hour after turning the patients to the prone position |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |