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

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Drug: Desflurane; Drug: Remimazolam

• Registration Number: NCT05774366
• Lead Sponsor: Daegu Catholic University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Study Start: 2023-03-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane group	Desflurane	receives desflurane for the maintenance of general anesthesia.
Remimazolam group	Remimazolam	receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.

Primary Outcome Measures

Name	Time	Method
Time to follow verbal command	from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes	Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot

Secondary Outcome Measures

Name	Time	Method
time to eye opening	from discontinuation of anesthetic agent to eye opening, up to 30 minutes	Time between discontinuation of anesthetic agent and eye opening
Incidence of agitation during emergence period	from discontinuation of anesthetic agent to 2 minutes after extubation	Ricker Sedation-Agitation Scale (RSAS) \>4
Mean arterial blood pressure	from 5 minutes before anesthesia induction to end of anesthesia	Mean arterial blood pressure measured in the operating room
time to extubation	form discontinuation of anesthetic agent to extubation, up to 30 minutes	Time between discontinuation of anesthetic agent and extubation

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of