A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration

Study Overview
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Brief Summary
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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. 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).

Official Title
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A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Conditions
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Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Intervention / Treatment
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* Drug: midazolam
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who visit Seoul National University Hospital between 2014.04 - 2015.04 Patients who undergo EBUS-TBNA during the period Aged between 18-75 Patients who meet the criteria of American Society of Anesthesiologists (ASA) physical status classification I-III Exclusion Criteria: American Society of Anesthesiologists (ASA) physical status classification >3 Have glomerular filtration rate (GFR) less than 15ml/min 1.73m2 or undergoing hemodialysis End stage liver disease. Impaired ventricular functions (EF <30%) Patients with baseline oxygen desaturation (resting SpO2 <90%) Asthma or chronic obstructive pulmonary disease or a forced expiratory volume in 1 s (FEV1)of < 1.0 liter Bradycardia [baseline heart rate (HR)< 60 beats/min] Hypotension [baseline systolic arterial pressure (SAP) < 100 mm Hg] Pregnant state Those intolerant or with an allergy to the study drug those unable or who refused to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midazolam<br>midazolam IV bolus 0.05ml/kg bolus in 1minute. rescue drug(Midazolam) 1 mg, IV boluses for double blinding setting, we use saline, 0.4 mcg/kg IV bolus in 10 minutes and 0.5 mcg/kg/h, as placebo. | Drug: midazolam<br> <br> |
| Experimental: Dexmedetomidine<br>Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.25-0.75 mcg/kg/h for RSS 3-5. Midazolam 1mg bolus IV pro re nata (PRN). for double blinding setting, IV bolus 0.05ml/kg bolus in 1minute. | Drug: Dexmedetomidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of Desaturation events | The number of desaturation (SpO2 <90% for more than 5 seconds) events | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSS score | RSS score: at the beginning of the procedure, minimum RSS score, every 5 minute | 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. | 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 | 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. | 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 | 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) |  | 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) | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |