Clinical trial NCT06275594: Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Midazolam
Remimazolam
Keywords: Remimazolam
Midazolam
Safety
Efficacy
EBUS-TBNA
Lead sponsor: Yeungnam University Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedural success during EBUS-TBNA (composite outcome)
timeFrame: Up to the end of the procedure (up to 1 hour)
Secondary outcomes:
measure: Time to start of procedure after administration of the first dose of study medication
timeFrame: Time from administration of the first dose of study medication to the start of procedure (MOAA/S ≤3) (up to 1 hour)
measure: Time taken to achieve full alertness after the procedure
timeFrame: Time from end of the procedure to first of three consecutive MOAA/S scores =5 (up to 1 hour)
measure: Requirement for flumazenil dosage during the procedure
timeFrame: From the end of procedure to discharge of bronchoscopy room (up to 1 hour)
measure: Total fentanyl dose
timeFrame: From the start of procedure to the end of procedure (up to 1 hour)
measure: Scale of coughing/discomfort/inconvenience
timeFrame: After the end of procedure (up to 1 hour)
measure: Changes in blood pressure
timeFrame: From the start of procedure to the end of procedure (up to 1 hour)
measure: Changes of heart rate
timeFrame: From the start of procedure to the end of procedure (up to 1 hour)
measure: Changes in respiration rate
timeFrame: From the start of procedure to the end of procedure (up to 1 hour)
measure: Complications related to the procedure
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Namgu
Study officials:
References: