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

Yeungnam University Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Remimazolam; Midazolam

Treatments: Drug: Byfavo; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06275594

YUMC2023-12-017

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 3 patient groups

Remimazolam

Experimental group

Description:

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

Treatment:

Drug: Byfavo

Real world Midazolam

Active Comparator group

Description:

Initial dosing 2-3mg, maintenance dosing: 0.5-1mg, interval ≥2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg

Treatment:

Drug: Midazolam

On label Midazolam

Active Comparator group

Description:

\<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

Treatment:

Drug: Midazolam