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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Remimazolam; Drug: Desflurane

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: So Young Lee, M.D.; Phone Number: +82-53-650-4885; Email: slamfor01@gmail.com
• Study Contact Backup: Name: Jonghae Kim, M.D.; Phone Number: +82-53-650-4979; Email: usmed12@gmail.com

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42472
    • Recruiting
    • Daegu Catholic University Medical Center
    • Contact: So Young Lee, M.D.; Phone Number: +82-53-650-4885; Email: slamfor01@gmail.com
    • Contact: Jong Hae Kim, M.D.; Phone Number: +82-53-650-4979; Email: usmed12@gmail.com
    • Principal Investigator: So Young Lee, M.D.
    • Sub-Investigator: Jong Hae Kim, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Principal Investigator: So Young Lee, M.D., Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Desflurane
• Other Study ID Numbers: CR-23-007-L

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No