1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated status for patients. * However, especially in bronchoscope procedure, continuous monitoring of oxygen saturation is needed to prevent hypoxia due to respiratory distress induced by benzodiazepine. * A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less adverse effect of respiratory distress compared to previous agents, was introduced. 2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA). * Double blind randomized trial * Primary outcome: The number and duration of desaturation, volume of sedative, any use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and hypertension, tachycardia, any need for mandible support or manual ventilation, and any need for intubation (for safety).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
110
Seoul National University Hospital
Seoul, South Korea
The number of Desaturation events
The number of desaturation (SpO2 \<90% for more than 5 seconds) events
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
RSS score
RSS score: at the beginning of the procedure, minimum RSS score, every 5 minute
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Total dose of intratracheal lidocaine instillation
Cumulative dose of lidocaine administered at bronchus by the endoscopist for local anesthesia by topical instillation. Topical lidocaine instillation is performed in both the two arms for procedure as routine bronchoscopy.
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Endoscopist satisfaction
Endoscopist global satisfaction score based on a VAS score
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room
Patient satisfaction
Global patient satisfaction associated with the procedure. Score based on a VAS score measured before the patients leave the bronchoscopy room.
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Use of rescue midazolam
Use of rescue midazolam, total dose
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Duration of desaturation (sec)
Time frame: Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
Hemodynamic adverse event
Hypotension ( \< mean BP 60 mmHg) Bradycardia ( \< 50 bpm)
Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
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