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The goal of this prospective, randomized study is to compare recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia in patients undergoing closed reduction of nasal bone fracture. The main question this study aims to answer is:
Participants will receive either remimazolam or desflurane for the maintenance of general anesthesia. When the surgery ends, the anesthetic agent will be stopped. For Remimazolam group, flumazenil will be administered as an antagonist of remimazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam. |
|
| Desflurane group | Active Comparator | receives desflurane for the maintenance of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | General anesthesia was induced with 12 mg/kg/hr of intravenous remimazolam. When loss of consciousness was achieved, the infusion rate of remimazolam was reduced to 1mg/kg/hr for maintenance. At the end of surgery, 0.2 mg of flumazenil is administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to follow verbal command | Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot | from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| time to eye opening | Time between discontinuation of anesthetic agent and eye opening | from discontinuation of anesthetic agent to eye opening, up to 30 minutes |
| time to extubation | Time between discontinuation of anesthetic agent and extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| So Young Lee, M.D. | Contact | +82-53-650-4885 | slamfor01@gmail.com | |
| Jonghae Kim, M.D. | Contact | +82-53-650-4979 | usmed12@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| So Young Lee, M.D. | Daegu Catholic University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu Catholic University Medical Center | Recruiting | Daegu | 42472 | South Korea |
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| Desflurane | Drug | Desflurane (1 minimum alveolar concentration (MAC) of end-tidal desflurane concentration) is used for the maintenance of general anesthesia. Induction of general anesthesia is achieved with 1-2 mg/kg of intravenous propofol bolus. |
|
| form discontinuation of anesthetic agent to extubation, up to 30 minutes |
| Incidence of agitation during emergence period | Ricker Sedation-Agitation Scale (RSAS) >4 | from discontinuation of anesthetic agent to 2 minutes after extubation |
| Mean arterial blood pressure | Mean arterial blood pressure measured in the operating room | from 5 minutes before anesthesia induction to end of anesthesia |
| ID | Term |
|---|---|
| C522201 | remimazolam |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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