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

Remimazolam Clinical Trial

— REST  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275594
• Other study ID #: YUMC2023-12-017
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Midazolam
• Remimazolam

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