Midazolam, Remimazolam
Conditions
Keywords
Remimazolam, Midazolam, Safety, Efficacy, EBUS-TBNA
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.
Interventions
DRUGByfavo
For induction and maintenance of sedation
DRUGMidazolam
For induction and maintenance of sedation
Sponsors
Yeungnam University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success during EBUS-TBNA (composite outcome) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 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) | 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. |
| Requirement for flumazenil dosage during the procedure | From the end of procedure to discharge of bronchoscopy room (up to 1 hour) | 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. |
| Total fentanyl dose | From the start of procedure to the end of procedure (up to 1 hour) | Total amount of fentanyl during the procedure |
| Complications related to the procedure | Up to 1 month | Procedure related complications during 1 month follow up |
| Changes in blood pressure | From the start of procedure to the end of procedure (up to 1 hour) | Changes of blood pressure (mmHg) assessed by 5 minutes |
| Changes of heart rate | From the start of procedure to the end of procedure (up to 1 hour) | Changes of heart rate (rates/minutes) assessed by 5 minutes |
| Changes in respiration rate | From the start of procedure to the end of procedure (up to 1 hour) | Changes of respiration rate (rates/minutes) assessed by 5 minutes |
| Scale of coughing/discomfort/inconvenience | After the end of procedure (up to 1 hour) | 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) |
Countries
South Korea
Contacts
Primary ContactJune Hong Ahn
Outcome results
None listed