Anesthesia
Conditions
Brief summary
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.
Interventions
DRUGRemimazolam
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.
DRUGDesflurane
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.
Sponsors
Daegu Catholic University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to follow verbal command | from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes | Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to eye opening | from discontinuation of anesthetic agent to eye opening, up to 30 minutes | Time between discontinuation of anesthetic agent and eye opening |
| time to extubation | form discontinuation of anesthetic agent to extubation, up to 30 minutes | Time between discontinuation of anesthetic agent and extubation |
| Incidence of agitation during emergence period | from discontinuation of anesthetic agent to 2 minutes after extubation | Ricker Sedation-Agitation Scale (RSAS) \>4 |
| Mean arterial blood pressure | from 5 minutes before anesthesia induction to end of anesthesia | Mean arterial blood pressure measured in the operating room |
Countries
South Korea
Contacts
Primary ContactSo Young Lee, M.D.
Backup ContactJonghae Kim, M.D.
Outcome results
None listed