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Participants will be randomly assigned to receive general anesthesia with either remimazolaml-based total intravenous anesthesia reversed with flumazenil or propofol-based total intravenous anesthesia. The primary outcome is the incidence of emergence agitation evaluated at the time of awakening after surgery. Additional outcomes include time to extubation, hemodynamic stability, airway complications such as coughing or laryngospasm, and postoperative recovery profiles including pain, nausea, vomiting, and sedation in the post-anesthesia care unit. This study aims to determine whether remimazolam with flumazenil provides smoother emergence compared with propofol in patients undergoing nasal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | Participants receive general anesthesia induced and maintained with remimazolam-based total intravenous anesthesia. At the end of surgery, flumazenil (0.2-1.0 mg) is administered to reverse the sedative effect. |
|
| Propofol | Active Comparator | Participants receive general anesthesia induced and maintained with propofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam with Flumazenil | Drug | General anesthesia is induced and maintained with remimazolam (initial infusion approximately 6 mg/kg/hr for induction, then 1-2 mg/kg/hr for maintenance), along with remifentanil for analgesia. At the end of surgery, flumazenil is administered to reverse the sedative effect, starting with 0.2 mg IV, followed by 0.1 mg incremental doses every 1 minute as needed, up to a total dose of 1.0 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Emergence Agitation | From discontinuation of anesthesia to exit in the operating room |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tracheal Extubation | From anesthesia discontinuation to extubation in the operating room | |
| Intraoperative Hemodynamic Stability | During anesthesia | |
| Incidence of Airway Complications During Emergence |
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Inclusion Criteria
- Adults aged 19 years or older scheduled to undergo nasal surgery requiring general anesthesia
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung Won Shin | Contact | 02-2072-2469 | skwskw126@gmail.com |
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|
| Propofol | Drug | General anesthesia is induced and maintained with propofol using target-controlled infusion (effect-site concentration up to 4.0 μg/mL), along with remifentanil for analgesia. |
|
Complications such as coughing, desaturation, and laryngospasm will be recorded based on direct observation by anesthesiologists. |
| during anesthesia |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D005442 | Flumazenil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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