Clinical trial NCT02157818: A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration
Official title: A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: The number of Desaturation events
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Secondary outcomes:
measure: RSS score
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
measure: Total dose of intratracheal lidocaine instillation
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
measure: Endoscopist satisfaction
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room
measure: Patient satisfaction
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
measure: Use of rescue midazolam
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
measure: Duration of desaturation (sec)
timeFrame: Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
measure: Hemodynamic adverse event
timeFrame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim J, Choi SM, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Lee J. Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):534-540. doi: 10.1097/EJA.0000000000001370.