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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 31, 2023

Interventions

• Drug: Remimazolam
  • General anesthesia was induced with 12mg/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.
• Drug: Desflurane
  • Desflurane (1 MAC of end-tidal desflurane concentration) is used for the maintenance of general anesthesia. Induction of general anesthesia is achieved with 1-2mg/kg of intravenous propofol bolus.

Arms, Groups and Cohorts

• Experimental: Remimazolam group
  • receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.
• Active Comparator: Desflurane group
  • receives desflurane for the maintenance of general anesthesia.

Clinical Trial Outcome Measures

Primary Measures

• Time to follow verbal command
  • Time Frame: from discontinuation of anesthetic agent to response to a verbal command of moving participant’s foot
  • Time between discontinuation of anesthetic agent and response to a verbal command of moving participant’s foot

Secondary Measures

• time to eye opening
  • Time Frame: from discontinuation of anesthetic agent to eye opening.
  • Time between discontinuation of anesthetic agent and eye opening
• time to extubation
  • Time Frame: form discontinuation of anesthetic agent to extubation
  • Time between discontinuation of anesthetic agent and extubation
• Incidence of agitation during emergence period
  • Time Frame: from discontinuation of anesthetic agent to 2 minutes after extubation
  • Ricker Sedation-Agitation Scale >4
• Mean arterial blood pressure
  • Time Frame: from 5 minutes before anesthesia induction to end of anesthesia
  • Mean arterial blood pressure measured in the operating room

Participating in This Clinical Trial

Inclusion Criteria

• Age between 19 and 75 years – American Society of Anesthesiologists physical status 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 >30 kg/m^2

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Daegu Catholic University Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: SO YOUNG LEE, Assistant professor – Daegu Catholic University Medical Center
• Overall Official(s)
  • So Young Lee, M.D., Principal Investigator, Daegu Catholic University Medical Center
• Overall Contact(s)
  • So Young Lee, M.D., +82-53-650-4885, slamfor01@gmail.com