A Prospective, Open-label, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam in patienTs Undergoing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration: REST Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Procedural success during EBUS-TBNA (composite outcome)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult males and females aged 18 and above
- •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
Exclusion Criteria
- •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
Arms & Interventions
Remimazolam
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
Intervention: Byfavo (Drug)
Real world Midazolam
Initial dosing 2-3mg, maintenance dosing: 0.5-1mg, interval ≥2minutes Remimazolam dose limitation: 7.5mg Fentanyl: 25-50mcg, interval ≥5mintues, max: 200mcg
Intervention: Midazolam (Drug)
On label 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
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
Procedural success during EBUS-TBNA (composite outcome)
Time Frame: 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 Outcomes
- Total fentanyl dose(From the start of procedure to the end of procedure (up to 1 hour))
- Changes of heart rate(From the start of procedure to the end of procedure (up to 1 hour))
- 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))
- Requirement for flumazenil dosage during the procedure(From the end of procedure to discharge of bronchoscopy room (up to 1 hour))
- Changes in respiration rate(From the start of procedure to the end of procedure (up to 1 hour))
- Complications related to the procedure(Up to 1 month)
- 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))
- Scale of coughing/discomfort/inconvenience(After the end of procedure (up to 1 hour))
- Changes in blood pressure(From the start of procedure to the end of procedure (up to 1 hour))
Investigators
June Hong Ahn
Associate professor
Yeungnam University Hospital