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MidazolamPhase 2RESTNCT06275594

Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

A Phase 2 study testing Byfavo and Midazolam in people with Midazolam and Remimazolam, run by Yeungnam University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Midazolam, Remimazolam
What is being tested?
Byfavo and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteSouth Korea
Study dates
1 Mar 2024to 1 Feb 2025
Phase
Phase 2
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

  • Adult males and females aged 18 and above
  • ASA 1-3
  • BMI 18.5~30.0
  • Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support
  • Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves

Who cannot join

  • Patients undergoing radial EBUS or electromagnetic navigation bronchoscopy (ENB) simultaneously
  • ASA 4 or higher
  • Mallampati score 4
  • BMI < 18.5, BMI >30.0
  • Known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition in which these agents
  • Bronchoscopy outside the bronchoscopy unit
Show all 9Show fewer
  • chronic kidney disease on dialysis
  • Patients with a current active acute infection or uncontrolled chronic inflammatory lung disease
  • Patients considered inappropriate for the study at the investigator's discretion

Trial locations and contacts

1 site in 1 country.

June Hong Ahn contact

821028562008

fireajh@gmail.com

South Korea1 site

  • Yeungnam University Hospital

    Daegu, Namgu, 42415

    June Hong Ahn, M.D. PhD, 821028562008, fireajh@gmail.com

Other trials in South Korea

About this study

Official title: A Prospective, Open-label, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam in patienTs Undergoing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration: REST Trial

Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration

Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).

Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure.

Being tested
Byfavo, Midazolam
Keywords
Remimazolam, Midazolam, Safety, Efficacy, EBUS-TBNA

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 groups in NCT06275594
Study groupRoleWhat they receive
RemimazolamExperimentalAmerican Society of Anesthesiologists (ASA) I-II: initial dosing 5mg, maintenance dosing: 2.5mg, interval ≥2minutes ASA III: initial dosing 2.5mg, maintenance dosing: 1.25mg, interval ≥2minutes Remimazolam dose limitation: none Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg
Receives: Drug: Byfavo
Real world MidazolamActive comparatorInitial dosing 2-3mg, maintenance dosing: 0.5-1mg, interval ≥2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg
Receives: Drug: Midazolam
On label MidazolamActive comparator<60years old and healthy: initial dosing 1.75mg, maintenance dosing: 1.0mg, interval ≥2minutes ≥60years old or debilitated/chronically ill: initial dosing 1.0mg, maintenance dosing: 0.5mg, interval v2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural success during EBUS-TBNA (composite outcome)

    Success of the bronchoscopy procedure, Completion of the bronchoscopy procedure, No requirement for a rescue sedative medication, In the case of remimazolam and placebo, no requirement for more than 5 top-ups of study medication within any 15 minute period; in the case of midazolam, no requirement for more than 3 doses in any 12 minute window

    Measured: Up to the end of the procedure (up to 1 hour)

Secondary outcomes (9)

  1. Time to start of procedure after administration of the first dose of study medication

    Modified Observer's Assessment of Alertness and Sedation (MOAA/S)≤3 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: Time from administration of the first dose of study medication to the start of procedure (MOAA/S ≤3) (up to 1 hour)

  2. Time taken to achieve full alertness after the procedure

    MOAA/S=5 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: Time from end of the procedure to first of three consecutive MOAA/S scores =5 (up to 1 hour)

  3. Requirement for flumazenil dosage during the procedure

    If MOAA/S score 5 is not reached after bronchoscopy, flumazenil will be administered. Total amount of flumazenil dosage during the procedure is measured.

    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: From the end of procedure to discharge of bronchoscopy room (up to 1 hour)

  4. Total fentanyl dose

    Total amount of fentanyl during the procedure

    Measured: From the start of procedure to the end of procedure (up to 1 hour)

  5. Scale of coughing/discomfort/inconvenience

    Coughing/discomfort/convenience visual analogue scale (Patients mark a point on a straight line corresponding to their perception of the severity of the cough, discomfort, and inconvenience. VAS ranges 0-100, with 0 representing minimal severity and 100 representing maximal severity)

    Measured: After the end of procedure (up to 1 hour)

  6. Changes in blood pressure

    Changes of blood pressure (mmHg) assessed by 5 minutes

    Measured: From the start of procedure to the end of procedure (up to 1 hour)

  7. Changes of heart rate

    Changes of heart rate (rates/minutes) assessed by 5 minutes

    Measured: From the start of procedure to the end of procedure (up to 1 hour)

  8. Changes in respiration rate

    Changes of respiration rate (rates/minutes) assessed by 5 minutes

    Measured: From the start of procedure to the end of procedure (up to 1 hour)

  9. Complications related to the procedure

    Procedure related complications during 1 month follow up

    Measured: Up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275594
Sponsor's protocol ID
YUMC2023-12-017
Acronym
REST
Status last verified
Feb 2024
First submitted
16 Jan 2024
Last updated
23 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seol HY, Hong KS, Jang JG, Moon SM, Kim SH, Cho JY, Yang B, Kim S, Choi CM, Ji W, Ahn JH. A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design. BMC Pulm Med. 2024 May 17;24(1):243. doi: 10.1186/s12890-024-03067-w.

    PubMed 38760702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Byfavo and Midazolam in people with Midazolam and Remimazolam, run by Yeungnam 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 5 inclusion and 9 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 23 Feb 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 June Hong Ahn (821028562008, fireajh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success during EBUS-TBNA (composite outcome) (time frame: Up to the end of the procedure (up to 1 hour)). 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 NCT06275594, 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 23 Feb 2024.

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