Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture

Study Overview
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Brief Summary
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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: Is there statistically significant difference in time from discontinuation of the anesthetic agent up to patient's response to verbal command between these two groups? 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.

Official Title
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Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 and 75 years American Society of Anesthesiologists physical status (ASA PS) of I-II Patients undergoing elective closed reduction of nasal bone fracture Exclusion Criteria: Patient who cannot understand the process of this study Cognitive, visual or hearing impairment Chronic use of antipsychotic medications or medications for sleeping problem Use of benzodiazepine Patient with kidney or liver disease Body mass index (BMI) >30 kg/m^2

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam group<br>receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam. | Drug: Remimazolam<br>* 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.<br>|
| Active Comparator: Desflurane group<br>receives desflurane for the maintenance of general anesthesia. | Drug: Desflurane<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |