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

Phase 2

Not yet recruiting

• Conditions: Remimazolam; Midazolam
• Interventions: Drug: Midazolam; Drug: Byfavo

• Registration Number: NCT06275594
• Lead Sponsor: Yeungnam University Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-16
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Study Start: 2024-03-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Adult males and females aged 18 and above
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

1. Patients undergoing radial EBUS or electromagnetic navigation bronchoscopy (ENB) simultaneously
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real world Midazolam	Midazolam	Initial dosing 2-3mg, maintenance dosing: 0.5-1mg, interval ≥2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg
Remimazolam	Byfavo	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
On label Midazolam	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

Primary Outcome Measures

Name	Time	Method
Procedural success during EBUS-TBNA (composite outcome)	Up to the end of the procedure (up to 1 hour)	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

Secondary Outcome Measures

Name	Time	Method
Total fentanyl dose	From the start of procedure to the end of procedure (up to 1 hour)	Total amount of fentanyl during the procedure
Changes of heart rate	From the start of procedure to the end of procedure (up to 1 hour)	Changes of heart rate (rates/minutes) assessed by 5 minutes
Time to start of procedure after administration of the first dose of study medication	Time from administration of the first dose of study medication to the start of procedure (MOAA/S ≤3) (up to 1 hour)	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.
Requirement for flumazenil dosage during the procedure	From the end of procedure to discharge of bronchoscopy room (up to 1 hour)	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.
Changes in respiration rate	From the start of procedure to the end of procedure (up to 1 hour)	Changes of respiration rate (rates/minutes) assessed by 5 minutes
Complications related to the procedure	Up to 1 month	Procedure related complications during 1 month follow up
Time taken to achieve full alertness after the procedure	Time from end of the procedure to first of three consecutive MOAA/S scores =5 (up to 1 hour)	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.
Scale of coughing/discomfort/inconvenience	After the end of procedure (up to 1 hour)	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)
Changes in blood pressure	From the start of procedure to the end of procedure (up to 1 hour)	Changes of blood pressure (mmHg) assessed by 5 minutes

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Namgu, Korea, Republic of