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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774366
• Other study ID #: CR-23-007-L
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Daegu Catholic University Medical Center
• Contact: So Young Lee, M.D.
• Phone: +82-53-650-4885
• Email: slamfor01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anesthesia
• Fractures, Bone

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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