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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05774366
Other study ID # CR-23-007-L
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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