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

Seoul National University

Status: Completed

Conditions: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Treatments: Drug: midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02157818

dex512

Details and patient eligibility

About

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).

Enrollment: 110 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

midazolam

Active Comparator group

Description:

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.

Treatment:

Drug: midazolam

Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine