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Clinical Trials/NCT05774366
NCT05774366
Recruiting
Not Applicable

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

Daegu Catholic University Medical Center1 site in 1 country58 target enrollmentMarch 22, 2023

Overview

Phase
Not Applicable
Intervention
Remimazolam
Conditions
Anesthesia
Sponsor
Daegu Catholic University Medical Center
Enrollment
58
Locations
1
Primary Endpoint
Time to follow verbal command
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2023
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daegu Catholic University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

SO YOUNG LEE

Assistant professor

Daegu Catholic University Medical Center

Eligibility Criteria

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

Arms & Interventions

Remimazolam group

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

Intervention: Remimazolam

Desflurane group

receives desflurane for the maintenance of general anesthesia.

Intervention: Desflurane

Outcomes

Primary Outcomes

Time to follow verbal command

Time Frame: 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 Outcomes

  • time to eye opening(from discontinuation of anesthetic agent to eye opening, up to 30 minutes)
  • Incidence of agitation during emergence period(from discontinuation of anesthetic agent to 2 minutes after extubation)
  • Mean arterial blood pressure(from 5 minutes before anesthesia induction to end of anesthesia)
  • time to extubation(form discontinuation of anesthetic agent to extubation, up to 30 minutes)

Study Sites (1)

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