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A Prospective, observational study to evaluate the Efficacy and Safety of remimazolam in patienTs undergoing EndoBronchial Ultrasound-guided TransBronchial Needle Aspiration: REST study

A prospective, open-label, Randomized observational study to evaluate the Efficacy and Safety of remimazolam in patienTs undergoing EndoBronchial Ultrasound-guided TransBronchial Needle Aspiration: REST study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009439
Enrollment
330
Registered
2024-05-17
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yeongnam University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult males and females aged 19 and above 2) ASA 1-3 3) BMI 18.5~30.0 4) SpO2 = 90% in ambient air or with no more than 2L/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

Exclusion criteria: 1) Patients undergoing both Radial EBUS and ENB simultaneously 2) ASA 4 or higher 3) Mallampati score 4 4) 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) CKD 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

MeasureTime frame
Procedural success during EBUS-TBNA (composite outcome)

Secondary

MeasureTime frame
Time to start of procedure after administration of the first dose of study medication;Requirement for flumazenil dosage during the procedure;Time taken to achieve full alertness after the procedure;Total fentanyl dose;Complications related to the procedure

Countries

Korea, Republic of

Contacts

Public ContactJune Hong Ahn

Yeongnam University Medical Center

fireajh@gmail.com+82-53-640-6552

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026