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

Daegu Catholic University Medical Center

Status: Enrolling

Conditions: Anesthesia

Treatments: Drug: Remimazolam; Drug: Desflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT05774366

CR-23-007-L

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Remimazolam group

Experimental group

Description:

receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.

Treatment:

Drug: Remimazolam

Desflurane group

Active Comparator group

Description:

receives desflurane for the maintenance of general anesthesia.

Treatment:

Drug: Desflurane