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

NCT06275594 | Not Yet Recruiting Phase 2

• 1 other identifier: YUMC2023-12-017
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Midazolam; Remimazolam

Keywords

Remimazolam; Midazolam; Safety; Efficacy; EBUS-TBNA

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• 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)

• 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)

• Requirement for flumazenil dosage during the procedure

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

• Total fentanyl dose

  From the start of procedure to the end of procedure (up to 1 hour)

• Scale of coughing/discomfort/inconvenience

  After the end of procedure (up to 1 hour)

Study Arms (3)

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

Drug: Byfavo

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

Drug: Midazolam

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

Drug: Midazolam

Interventions

Byfavo DRUG

For induction and maintenance of sedation

Also known as: Remimazolam

Remimazolam

Midazolam DRUG

For induction and maintenance of sedation

On label Midazolam; Real world Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females aged 18 and above
• ASA 1-3
• BMI 18.5\~30.0
• Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support
• Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves

You may not qualify if:

• Patients undergoing radial EBUS or electromagnetic navigation bronchoscopy (ENB) simultaneously
• ASA 4 or higher
• Mallampati score 4
• BMI \< 18.5, BMI \>30.0
• Known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition in which these agents
• Bronchoscopy outside the bronchoscopy unit
• chronic kidney disease on dialysis
• Patients with a current active acute infection or uncontrolled chronic inflammatory lung disease
• Patients considered inappropriate for the study at the investigator's discretion

Sponsors & Collaborators

• Yeungnam University Hospital: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, Namgu, 42415, South Korea

Location

Related Publications (1)

• 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.

  PMID: 38760702 DERIVED

MeSH Terms

Interventions

remimazolam; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

June Hong Ahn

CONTACT

821028562008; fireajh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 23, 2024
• Study Start: March 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)