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This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.
This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination group | Experimental | Combination regimen (remimazolam plus propofol) |
|
| Propofol group | Active Comparator | Propofol monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate + propofol MCT | Drug | remimazolam besylate 3mg/kg/hr for induction, and 0.5 mg/kg/hr for maintenance + propofol MCT 1-4 mcg/ml using target-controlled infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative hypotension | mean arterial pressure < 65mmHg | operation day - postoperative 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Amount and number of inotropic agents | intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg)) | operation day - postoperative 1 day |
| Incidence of participants' intraoperative involuntary movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiwon Han, Pf. | Contact | 821034471988 | yesuroon@gmail.com |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol MCT | Drug | Propofol MCT 2-8 mcg/ml using target-controlled infusion |
|
number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3)
| operation day - postoperative 1 day |
| scores of neurophysiologic monitoring quality | 0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5) | operation day - postoperative 1 day |
| onset time of study drugs | time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value < 60 | operation day - postoperative 1 day |
| The administration number of rescue anti-emetic agents | postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements | operation day - postoperative 3 day |
| Time-weighted average of intraoperative hypotension | (depth of hypotension in millimeters of mercury below a MAP of 65mmHg × time in minutes spent below a MAP of 65mmHg)÷total duration of operation in minutes | operation day - postoperative 1 day |
| recovery time of study drugs (remimazolam+propofol or propofol) | time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value > 60 | operation day - postoperative 1 day |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |