- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157818
A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration
A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 110-799
- Seoul National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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: 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
Time Frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
|
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
Time Frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room
|
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
Time Frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
|
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
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, 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)
Time Frame: Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
|
Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
|
|
Hemodynamic adverse event
Time Frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
- Dexmedetomidine
Other Study ID Numbers
- dex512
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