Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
NCT ID: NCT06275594
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
330 participants
INTERVENTIONAL
2024-03-01
2025-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Remimazolam
American 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
Byfavo
For induction and maintenance of sedation
Real world Midazolam
Initial dosing 2-3mg, maintenance dosing: 0.5-1mg, interval ≥2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg
Midazolam
For induction and maintenance of sedation
On label Midazolam
\<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
Midazolam
For induction and maintenance of sedation
Interventions
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Byfavo
For induction and maintenance of sedation
Midazolam
For induction and maintenance of sedation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ASA 1-3
3. BMI 18.5\~30.0
4. Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support
5. Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves
Exclusion Criteria
2. ASA 4 or higher
3. Mallampati score 4
4. BMI \< 18.5, BMI \>30.0
5. Known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition in which these agents
6. Bronchoscopy outside the bronchoscopy unit
7. chronic kidney disease on dialysis
8. Patients with a current active acute infection or uncontrolled chronic inflammatory lung disease
9. Patients considered inappropriate for the study at the investigator's discretion
18 Years
ALL
No
Sponsors
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Yeungnam University Hospital
OTHER
Responsible Party
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June Hong Ahn
Associate professor
Locations
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Yeungnam University Hospital
Daegu, Namgu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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YUMC2023-12-017
Identifier Type: -
Identifier Source: org_study_id
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