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RecruitingNCT05774366Updated Sep 7, 2023

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

An interventional study of Remimazolam and Desflurane in Anesthesia, sponsored by Daegu Catholic University Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 19 and 75 years
  • physical status (ASA PS) of I-II
  • Patients undergoing elective closed reduction of nasal bone fracture

Exclusion criteria

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
  • (BMI) >30 kg/m\^2
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Remimazolam group

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

    Drug: Remimazolam

  • Active comparator
    Desflurane group

    receives desflurane for the maintenance of general anesthesia.

    Drug: Desflurane

Interventions

  • 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 (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.

06

What researchers measure

Primary outcomes

  1. Time to follow verbal command

    Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot

    Time frame: from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes

Secondary outcomes

  1. time to eye opening

    Time between discontinuation of anesthetic agent and eye opening

    Time frame: from discontinuation of anesthetic agent to eye opening, up to 30 minutes

  2. time to extubation

    Time between discontinuation of anesthetic agent and extubation

    Time frame: form discontinuation of anesthetic agent to extubation, up to 30 minutes

  3. Incidence of agitation during emergence period

    Ricker Sedation-Agitation Scale (RSAS) \>4

    Time frame: from discontinuation of anesthetic agent to 2 minutes after extubation

  4. Mean arterial blood pressure

    Mean arterial blood pressure measured in the operating room

    Time frame: from 5 minutes before anesthesia induction to end of anesthesia

07

Study locations

1 of 1 sites recruiting
  • Daegu Catholic University Medical Center
    Daegu, 42472, Korea, Republic of
    Recruiting
    • So Young Lee, M.D. · Contactslamfor01@gmail.com · +82-53-650-4885
    • Jong Hae Kim, M.D. · Contactusmed12@gmail.com · +82-53-650-4979
    • So Young Lee, M.D. · Principal investigator
    • Jong Hae Kim, M.D. · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Dec 2023, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2023
First posted
Mar 17, 2023
StartActual
Mar 22, 2023
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Sep 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05774366
Lead sponsor
Daegu Catholic University Medical Center
Responsible party
SO YOUNG LEE (Assistant professor, Daegu Catholic University Medical Center) — Principal investigator
First posted
Mar 17, 2023
Start date
Mar 22, 2023
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Sep 7, 2023

Study contacts

So Young Lee, M.D.
Contact
slamfor01@gmail.com
+82-53-650-4885
Jonghae Kim, M.D.
Contact
usmed12@gmail.com
+82-53-650-4979
So Young Lee, M.D.
principal investigator · Daegu Catholic University Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Remimazolam

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