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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06275594
Other study ID # YUMC2023-12-017
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2024
Est. completion date February 1, 2025

Study information

Verified date February 2024
Source Yeungnam University Hospital
Contact June Hong Ahn
Phone 821028562008
Email fireajh@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 330
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Byfavo
For induction and maintenance of sedation
Midazolam
For induction and maintenance of sedation

Locations

Country Name City State
Korea, Republic of Yeungnam University Hospital Daegu Namgu

Sponsors (1)

Lead Sponsor Collaborator
Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 from administration of the first dose of study medication to the start of procedure (MOAA/S =3) (up to 1 hour)
Secondary 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 from end of the procedure to first of three consecutive MOAA/S scores =5 (up to 1 hour)
Secondary 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.
From the end of procedure to discharge of bronchoscopy room (up to 1 hour)
Secondary Total fentanyl dose Total amount of fentanyl during the procedure From the start of procedure to the end of procedure (up to 1 hour)
Secondary 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) After the end of procedure (up to 1 hour)
Secondary Changes in blood pressure Changes of blood pressure (mmHg) assessed by 5 minutes From the start of procedure to the end of procedure (up to 1 hour)
Secondary Changes of heart rate Changes of heart rate (rates/minutes) assessed by 5 minutes From the start of procedure to the end of procedure (up to 1 hour)
Secondary Changes in respiration rate Changes of respiration rate (rates/minutes) assessed by 5 minutes From the start of procedure to the end of procedure (up to 1 hour)
Secondary Complications related to the procedure Procedure related complications during 1 month follow up Up to 1 month
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