AnesthesiaNCT05774366
Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
A study testing Remimazolam and Desflurane in people with Anesthesia, run by Daegu Catholic University Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remimazolam and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Daegu Catholic University Medical Center
Daegu, 42472
So Young Lee, M.D., +82-53-650-4885, slamfor01@gmail.com
Jong Hae Kim, M.D., +82-53-650-4979, usmed12@gmail.com
About this study
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.
- Conditions
- Anesthesia
- Being tested
- Remimazolam, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
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.
DesfluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam. Receives: Drug: Remimazolam |
| Desflurane group | Active comparator | receives desflurane for the maintenance of general anesthesia. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to follow verbal command
Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot
Measured: from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes
Secondary outcomes (4)
time to eye opening
Time between discontinuation of anesthetic agent and eye opening
Measured: from discontinuation of anesthetic agent to eye opening, up to 30 minutes
time to extubation
Time between discontinuation of anesthetic agent and extubation
Measured: form discontinuation of anesthetic agent to extubation, up to 30 minutes
Incidence of agitation during emergence period
Ricker Sedation-Agitation Scale (RSAS) >4
Measured: from discontinuation of anesthetic agent to 2 minutes after extubation
Mean arterial blood pressure
Mean arterial blood pressure measured in the operating room
Measured: from 5 minutes before anesthesia induction to end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start22 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SO YOUNG LEE, Daegu Catholic University Medical Center
- Investigators
- So Young Lee, M.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774366
- Sponsor's protocol ID
- CR-23-007-L
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
- ClinicalTrials.gov ID
- NCT05774366
- Acronym / sponsor ID
- CR-23-007-L
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolamreceives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam. |
| Desflurane group | Active comparator | Drug: Desfluranereceives desflurane for the maintenance of general anesthesia. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamGeneral 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. | Drug | Remimazolam group |
| DesfluraneDesflurane (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. | Drug | Desflurane group |
Primary outcome
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
4 secondary outcomes
time to eye opening
Time frame: from discontinuation of anesthetic agent to eye opening, up to 30 minutes
time to extubation
Time frame: form discontinuation of anesthetic agent to extubation, up to 30 minutes
Incidence of agitation during emergence period
Time frame: from discontinuation of anesthetic agent to 2 minutes after extubation
Mean arterial blood pressure
Time frame: from 5 minutes before anesthesia induction to end of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
So Young Lee, M.D. principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Desflurane in people with Anesthesia, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact So Young Lee, M.D. (+82-53-650-4885, slamfor01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.