Endobronchial Ultrasound Guided Transbronchial Needle AspirationNCT02157818
A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration
A study testing midazolam and Dexmedetomidine in people with Endobronchial Ultrasound Guided Transbronchial Needle Aspiration, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
- What is being tested?
- midazolam and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
- 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).
- Being tested
- midazolam, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Active comparator | 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. Receives: Drug: midazolam |
| Dexmedetomidine | Experimental | 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Desaturation events
The number of desaturation (SpO2 <90% for more than 5 seconds) events
Measured: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Secondary outcomes (7)
RSS score
RSS score: at the beginning of the procedure, minimum RSS score, every 5 minute
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endobronchial Ultrasound Guided Transbronchial Needle AspirationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwoo Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157818
- Sponsor's protocol ID
- dex512
- Status last verified
- May 2017
- First submitted
- 1 Jun 2014
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33122573
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
- ClinicalTrials.gov ID
- NCT02157818
- Acronym / sponsor ID
- dex512
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam | Active comparator | Drug: midazolammidazolam 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. |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolam | Drug | midazolam |
| Dexmedetomidine | Drug | Dexmedetomidine |
Primary outcome
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
7 secondary outcomes
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
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
Endoscopist satisfaction
Time frame: 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
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
Duration of desaturation (sec)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Derived from this study: PubMed 33122573Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam and Dexmedetomidine in people with Endobronchial Ultrasound Guided Transbronchial Needle Aspiration, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.