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

Seoul National University Hospital1 site in 1 country110 target enrollmentJune 2014

ConditionsEndobronchial Ultrasound Guided Transbronchial Needle Aspiration

Interventionsmidazolam Dexmedetomidine

Drugsmidazolam Dexmedetomidine

Overview

Phase: Not Applicable
Intervention: midazolam
Conditions: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Sponsor: Seoul National University Hospital
Enrollment: 110
Locations: 1
Primary Endpoint: The number of Desaturation events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

December 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jinwoo Lee

Professor

Seoul National University Hospital

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

Arms & Interventions

midazolam

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.

Intervention: midazolam

Dexmedetomidine

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.

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

The number of Desaturation events

Time Frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

The number of desaturation (SpO2 \<90% for more than 5 seconds) events

Secondary Outcomes

Total dose of intratracheal lidocaine instillation(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)
RSS score(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
Endoscopist satisfaction(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room)
Patient satisfaction(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(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
Hemodynamic adverse event(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)