A Prospective, observational study to evaluate the Efficacy and Safety of remimazolam in patienTs undergoing EndoBronchial Ultrasound-guided TransBronchial Needle Aspiration: REST study
- Conditions
- Neoplasms
- Registration Number
- KCT0009439
- Lead Sponsor
- Yeongnam University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 330
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 ,
1)Patients undergoing both Radial EBUS and ENB simultaneously
2)ASA 4 or higher
3)Mallampati score 4
4)BMI < 18.4, 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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural success during EBUS-TBNA (composite outcome)
- Secondary Outcome Measures
Name Time Method 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