BronchoscopyPhase 4NCT05994547
Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial
A Phase 4 study testing Byfavo and Midazolam in people with Bronchoscopy and Remimazolam, run by Chungbuk National University Hospital at 1 site in South Korea.
Trial summary
Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy, Remimazolam
- What is being tested?
- Byfavo and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2022to 15 Jun 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥18 years who required diagnostic or therapeutic bronchoscopy and agreed to participate
Who cannot join
- 1) pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3) mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
About this study
Official title: Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study
Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of remimazolam with that of midazolam for bronchoscopy.
Design: A single-center, prospective randomized parallel-group study
Read more
Setting: Chungbuk National University Hospital, April 2022-June 2023.
Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam group and 49 to the remimazolam group. Respiratory nurse specialists performed the randomization.
Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior to sedation. The vocal cords and lower airway tract were anesthetized.
Patients aged <60 years or weighing >50 kg received 3 mg intravenous midazolam or 5 mg remimazolam. Patients aged ≥60 years or weighing <50 kg received 2 mg intravenous midazolam or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3)
Main outcome measures: The primary outcome was the time from the end of the procedure to full alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and adverse effects.
- Conditions
- Bronchoscopy, Remimazolam
- Being tested
- Byfavo, Midazolam
- Keywords
- Remimazolam, midazolam, safety, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ByfavoDrug
Also called Remimazolam
For induction and maintenance of sedation
MidazolamDrug
For induction and maintenance of sedation
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Experimental | Patients aged <60 years or weighing >50 kg were randomly assigned to receive 3 mg intravenous midazolam. In contrast, those aged ≥60 years or with a body weight of <50 kg were assigned 2 mg intravenous.
If adequate sedation was not achieved after the initial sedative administration, additional midazolam (0.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician. Receives: Drug: Midazolam |
| Remimazolam | Active comparator | Patients aged <60 years or weighing >50 kg were randomly assigned to receive 5 mg remimazolam. In contrast, those aged ≥60 years or with a body weight of <50 kg were assigned intravenous 3 mg remimazolam.
If adequate sedation was not achieved after the initial sedative administration, additional remimazolam (2.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician. Receives: Drug: Byfavo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time from the end of the procedure to full alertness in both groups.
The Time for patient to recover Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores to 5 after end of bronchoscopy
MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.
MOAA/S scores were assessed by the investigators.
Measured: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
the time taken to reach peak sedation
The degree of sedation was measured using the Modified Observer's Alertness/Sedation scale (MOAA/S), and bronchoscopy was performed under adequate sedation (MOAA/S≤3)
Measured: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
Secondary outcomes (3)
physician satisfaction after the procedure
Physician satisfaction with sedation was expressed as a score ranging from -5 to 5 after completion of the procedure (-5 = not satisfied at all, 5 = maximally satisfied).
Measured: up to 1day
patient satisfaction after the procedure
Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).
Measured: up to 1day
difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.
adverse effects that occur during and after the procedure
Measured: up to 30days (the first dose to the end of the procedure was defined as the time from the first sedative drug administration to mouth exit.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start14 Apr 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchoscopyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumhee Yang, MD, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994547
- Sponsor's protocol ID
- Remimazolam Vs midazolam
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SH, Cho JY, Kim M, Chung JM, Yang J, Seong C, Kim EG, Seok JW, Shin YM, Lee KM, Choe KH, Han JH, Yang B. Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study. Sci Rep. 2023 Nov 22;13(1):20498. doi: 10.1038/s41598-023-47271-w.
PubMed 37993525
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05994547
- Acronym / sponsor ID
- Remimazolam Vs midazolam
- Conditions
- Bronchoscopy, Remimazolam
- Keywords
- Remimazolam, midazolam, safety, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chungbuk National University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 16 Aug 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.
Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of remimazolam with that of midazolam for bronchoscopy.
Design: A single-center, prospective randomized parallel-group study
Setting: Chungbuk National University Hospital, April 2022-June 2023.
Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam group and 49 to the remimazolam group. Respiratory nurse specialists performed the randomization.
Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior to sedation. The vocal cords and lower airway tract were anesthetized.
Patients aged <60 years or weighing >50 kg received 3 mg intravenous midazolam or 5 mg remimazolam. Patients aged ≥60 years or weighing <50 kg received 2 mg intravenous midazolam or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3)
Main outcome measures: The primary outcome was the time from the end of the procedure to full alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Experimental | Drug: MidazolamPatients aged <60 years or weighing >50 kg were randomly assigned to receive 3 mg intravenous midazolam. In contrast, those aged ≥60 years or with a body weight of <50 kg were assigned 2 mg intravenous. If adequate sedation was not achieved after the initial sedative administration, additional midazolam (0.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician. |
| Remimazolam | Active comparator | Drug: ByfavoPatients aged <60 years or weighing >50 kg were randomly assigned to receive 5 mg remimazolam. In contrast, those aged ≥60 years or with a body weight of <50 kg were assigned intravenous 3 mg remimazolam. If adequate sedation was not achieved after the initial sedative administration, additional remimazolam (2.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged ≥18 years who required diagnostic or therapeutic bronchoscopy and agreed to participate
Key exclusion criteria (1 listed)
- 1) pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3) mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation
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 |
|---|---|---|
| ByfavoAlso: RemimazolamFor induction and maintenance of sedation | Drug | Remimazolam |
| MidazolamFor induction and maintenance of sedation | Drug | Midazolam |
Primary outcome
the time from the end of the procedure to full alertness in both groups.
Time frame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
The Time for patient to recover Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores to 5 after end of bronchoscopy MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze. MOAA/S scores were assessed by the investigators.
the time taken to reach peak sedation
Time frame: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
The degree of sedation was measured using the Modified Observer's Alertness/Sedation scale (MOAA/S), and bronchoscopy was performed under adequate sedation (MOAA/S≤3)
3 secondary outcomes
physician satisfaction after the procedure
Time frame: up to 1day
patient satisfaction after the procedure
Time frame: up to 1day
difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.
Time frame: up to 30days (the first dose to the end of the procedure was defined as the time from the first sedative drug administration to mouth exit.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 37993525Kim SH, Cho JY, Kim M, Chung JM, Yang J, Seong C, Kim EG, Seok JW, Shin YM, Lee KM, Choe KH, Han JH, Yang B. Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study. Sci Rep. 2023 Nov 22;13(1):20498. doi: 10.1038/s41598-023-47271-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Byfavo and Midazolam in people with Bronchoscopy and Remimazolam, run by Chungbuk National University Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time from the end of the procedure to full alertness in both groups. (time frame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994547, which also lists 1 linked publication.
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 16 Aug 2023.