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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | 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 |
|
| Real world Midazolam | Active Comparator | Initial dosing 2-3mg, maintenance dosing: 0.5-1mg, interval ≥2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg |
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| On label Midazolam | Active 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Byfavo | Drug | For induction and maintenance of sedation |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to the end of the procedure (up to 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| June Hong Ahn | Contact | 821028562008 | fireajh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Hospital | Daegu | Namgu | 42415 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38760702 | Derived | 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. |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | For induction and maintenance of sedation |
|
| Time from administration of the first dose of study medication to the start of procedure (MOAA/S ≤3) (up to 1 hour) |
| 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. | Time from end of the procedure to first of three consecutive MOAA/S scores =5 (up to 1 hour) |
| 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. | From the end of procedure to discharge of bronchoscopy room (up to 1 hour) |
| Total fentanyl dose | Total amount of fentanyl during the procedure | From the start of procedure to the end of procedure (up to 1 hour) |
| 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) | After the end of procedure (up to 1 hour) |
| Changes in blood pressure | Changes of blood pressure (mmHg) assessed by 5 minutes | From the start of procedure to the end of procedure (up to 1 hour) |
| Changes of heart rate | Changes of heart rate (rates/minutes) assessed by 5 minutes | From the start of procedure to the end of procedure (up to 1 hour) |
| Changes in respiration rate | Changes of respiration rate (rates/minutes) assessed by 5 minutes | From the start of procedure to the end of procedure (up to 1 hour) |
| Complications related to the procedure | Procedure related complications during 1 month follow up | Up to 1 month |
| D006571 | Heterocyclic Compounds |