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

Phase 2Not Yet RecruitingNCT06275594

Yeungnam University Hospital330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

Midazolam Remimazolam

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

Time frame: 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 frame: 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.

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

Total fentanyl dose

Total amount of fentanyl during the procedure

Time frame: 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)

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

Changes in blood pressure

Changes of blood pressure (mmHg) assessed by 5 minutes

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 1 month

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts