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The purpose of this study is to compare the effects of remimazolam and propofol on postoperative recovery time, complications, and safety in patients undergoing ambulatory upper airway surgery under general anesthesia.
Patients scheduled for ambulatory upper airway (including nasal cavity, oral cavity, pharynx, larynx) surgery and who agree to participate in the study will be randomly assigned to the Remimazolam group and the Propofol group. In the Remimazolam group, general anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil. Once the surgery is completed, general anesthesia is recovered with flumazenil. In the Propofol group, general anesthesia is induced and maintained by continuous infusion of propofol and remifentanil using a target concentration controlled infusion method. In both groups, rocuronium is used for neuromuscular blokade, and sugammadex is used for reversal of neuromuscular blockade.
When the surgery is completed, recovery time, occurrence of adverse events, and anesthesia recovery indicators are examined in 3 stages: in the operating room, while staying in the post-anesthesia care unit(PACU), and while staying in the day surgery center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | General anesthesia is induced by continuously injecting remimazolam (6 mg/kg/h) and remifentanil (2-6 ng/ml, target concentration controlled infusion) through an infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6 mg/kg is injected for endotracheal intubation, and anesthesia is maintained with remimazolam (1-2 mg/kg/hr) and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated with flumazenil and sugammadex. |
|
| Propofol group | Active Comparator | General anesthesia is induced by continuously injecting propofol (2-6 mg/ml, target concentration controlled injection) and remifentanil (2-6 ng/ml, target concentration controlled injection) using a TCI infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6mg/kg is injected for endotracheal intubation, and anesthesia is maintained with propofol and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated through sugammadex. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fit-for-discharge time | Evaluated on a scale of 0 to 10 through the Modified Post Anesthetic Discharge Scoring System (MPADSS); a score of 9 or higher meets the discharge criteria. | 15 minutes after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer | Measured at operating room, using a timer from the end of surgery | 1 minute |
| postanesthetic care unit (PCAU) stay time, Day surgery center stay time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Se-Hee Min | Contact | +820222221534 | seiheemin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Se-Hee Min | Chung-Ang University Gwangmyeong Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChungAng University Gwangmyeong Hospital | Recruiting | Gyeonggi-do | Gwangmyeon-si | 14353 | South Korea |
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| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009059 | Mouth Diseases |
| D009668 | Nose Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009057 | Stomatognathic Diseases |
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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 | General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil. |
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Measured from entering to exiting each units
| 5 minutes |
| Incidence of adverse events | Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea & vomiting | 6 hours |
| Postoperative pain score | 11-point NRS (0-10); for the worst pain | 6 hours |
| modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival | Evaluated on a scale of 0 to 5 | 30 minutes |
| modified Aldrete score at PACU arrival | Evaluated on a scale of 0 to 10 | 30 minutes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |