Anesthesia Clinical Trial
Official title:
Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
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.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Daegu Catholic University Medical Center | Daegu |
Lead Sponsor | Collaborator |
---|---|
Daegu Catholic University Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | time to extubation | Time between discontinuation of anesthetic agent and extubation | form discontinuation of anesthetic agent to extubation, up to 30 minutes | |
Secondary | Incidence of agitation during emergence period | Ricker Sedation-Agitation Scale (RSAS) >4 | from discontinuation of anesthetic agent to 2 minutes after extubation | |
Secondary | Mean arterial blood pressure | Mean arterial blood pressure measured in the operating room | from 5 minutes before anesthesia induction to end of anesthesia |
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