BronchoscopyPhase 4NCT03521505

Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

A Phase 4 study testing Dexmedetomidine arm and Propofol arm in people with Bronchoscopy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Bronchoscopy
What is being tested?: Dexmedetomidine arm and Propofol arm
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTaiwan
Study dates: 11 May 2018to 22 Jan 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing elective bronchoscopy and sedation

Who cannot join

Age less than 20 years
American Society of Anaesthesiologists (ASA) physical status classification IV or V
Mallampati score of 4
Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
Body mass index more than 42 in males or 35 in females
Neurologic disorders or other conditions contributing to difficulty in assessing response

Show all 10Show fewer

Forced expiratory vital capacity (FVC) less than 15 ml/kg body weight, forced expiratory volume in one second (FEV1) less than 1000 ml, or FEV1/FVC less than 35%
History of second or third degree atrioventricular block, heat rate less than 50 beat per minute or systolic blood pressure less than 90 mmHg
Pregnancy
Patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: Dexmedetomidine and Brain Perfusion Monitor for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Preventing hypoxemia is one of the major goal of studies for bronchoscopic sedation. Dexmedetomidine is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. In the preset study, we evaluate the safety and feasibility of the Dexmedetomidine in the specific bronchoscopic procedure, endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration.

Read the detailed description

Patients undergoing flexible bronchoscopy (FB) experience procedure-related symptoms. Current guidelines of FB recommend sedation to all patients undergoing FB, except when there are contraindications. Propofol plus an opioid is the common combination used to improve patient tolerance and satisfaction during FB. However, controversy about combining propofol and opioids persists because of the risk of over-sedation and cardiopulmonary depression, especially for the time-consuming endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA). Similar with other published data, around 40% of hypoxemia event was observed during FB sedation in the investigators' hospital. Dexmedetomidine, is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. It has been applied in patients with mechanical ventilation, undergoing gastroendoscopy and extracorporal shockwave lithotripsy. Little evidences are available for Dexmedetomidine in sedation for EBUS-TBNA.

In this study, the investigators will evaluate the safety and feasibility of Dexmedetomidine for sedation of EBUS-TBNA comparing to Propofol for sedation of EBUS-TBNA. Generally, the FB sedation can divided into three parts: the induction (from starting sedative administration to insertion of bronchoscope); the maintenance ( from insertion of bronchoscope to its removal) and the recovery (from bronchoscope removal to patients gain consciousness). The primary endpoint is the proportion of patients with hypoxemia during maintenance of sedation. the investigators will also observe the other sedative outcomes, e.g. blood pressure, sedative drug dosing and patient tolerance and cooperation. The present study will also observe the association between brain perfusion and sedative outcomes via non-invasive monitor. Based on the unique pharmacokinetic property of Dexmedetomidine and the real-time brain perfusion monitor, Dexmedetomidine-based sedation may provide better safety profile for EBUS-TBNA than propofol and discover novel connection between sedative outcomes and brain perfusion.

Conditions: Bronchoscopy
Being tested: Dexmedetomidine arm, Propofol arm
Keywords: Sedation, dexmedetomidine, brain perfusion, bronchoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexmedetomidine armDrug
Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration
Propofol armDrug
5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2.
Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration.

Study groups in NCT03521505
Study group	Role	What they receive
Dexmedetomidine arm	Experimental	Dexmedetomidine will be administrated for sedation of EBUS-TBNA Receives: Drug: Dexmedetomidine arm
Propofol arm	Active comparator	Propofol will be administrated for sedation of EBUS-TBNA Receives: Drug: Propofol arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Hypoxemia During Maintenance
The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during maintenance of Bronchoscopic sedation
Measured: After starting bronchoscopy, up to 120 minutes

Secondary outcomes (6)

Hypoxemia During Induction
The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during induction of bronchoscopic sedation
Measured: After starting induction, up to 30 minutes.
The Global Tolerance for Bronchoscopy
The Global Tolerance of patients for bronchoscopy will be evaluated by 100-mm visual analogue scale (VAS, 0: no bother, 100: worst intolerable) after recovery
Measured: After recovery from sedation, up to 120 minutes
The Cooperation of Patients From the View of Bronchoscopists
The Cooperation of Patients will be evaluated by 100-mm visual analogue scale (VAS, 0: well cooperation, 100: worst cooperation) after recovery.
Measured: After recovery from sedation, up to 120 minutes
Hypotension During Bronchoscopic Sedation
The percentage of patients with hypotension (mean arterial blood pressure (MAP) less than 65 mmHg with any duration.
Measured: After starting sedation, up to 120 minutes.
Bradycardia During Bronchoscopic Sedation
The percentage of patients with bradycardia (heat beat per minute less than 60)
Measured: After starting sedation, up to 120 minutes.
Procedure Time and Recovery Time
The procedure time of bronchoscopy and recovery time from sedation to awake.
Measured: After starting bronchoscopy, up to 120 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 201822 Jan 2020

First posted11 May 2018
Study start11 May 2018
Primary completion22 Jan 2020
Study completion22 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for BronchoscopyStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03521505
Sponsor's protocol ID: 201601093A3
Status last verified: Aug 2021
First submitted: 16 Apr 2018
Last updated: 9 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.
PubMed 23638141
Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.
PubMed 22132138
Lin TY, Fang YF, Huang SH, Wang TY, Kuo CH, Wu HT, Kuo HP, Lo YL. Capnography monitoring the hypoventilation during the induction of bronchoscopic sedation: A randomized controlled trial. Sci Rep. 2017 Aug 17;7(1):8685. doi: 10.1038/s41598-017-09082-8.
PubMed 28819181
Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.
PubMed 22174346
Lin TY, Huang YC, Kuo CH, Chung FT, Lin YT, Wang TY, Lin SM, Lo YL. Dexmedetomidine sedation for endobronchial ultrasound-guided transbronchial needle aspiration, a randomised controlled trial. ERJ Open Res. 2020 Nov 10;6(4):00064-2020. doi: 10.1183/23120541.00064-2020. eCollection 2020 Oct.
PubMed 33693047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dexmedetomidine and Brain Perfusion Monitor for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration
ClinicalTrials.gov ID: NCT03521505
Acronym / sponsor ID: 201601093A3
Conditions: Bronchoscopy
Keywords: Sedation, dexmedetomidine, brain perfusion, bronchoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 11 May 2018 (actual)
Primary completion: 22 Jan 2020 (actual)
Study completion: 22 Jan 2020 (actual)
First posted: 11 May 2018 (actual)
Results: Posted 9 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine arm	Experimental	Drug: Dexmedetomidine armDexmedetomidine will be administrated for sedation of EBUS-TBNA
Propofol arm	Active comparator	Drug: Propofol armPropofol will be administrated for sedation of EBUS-TBNA

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing elective bronchoscopy and sedation

Key exclusion criteria (10 listed)

Age less than 20 years
American Society of Anaesthesiologists (ASA) physical status classification IV or V
Mallampati score of 4
Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
Body mass index more than 42 in males or 35 in females

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
Dexmedetomidine armInduction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration	Drug	Dexmedetomidine arm
Propofol arm5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2. Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration.	Drug	Propofol arm

Primary outcome

Hypoxemia During Maintenance
Time frame: After starting bronchoscopy, up to 120 minutes
The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during maintenance of Bronchoscopic sedation

6 secondary outcomes

Hypoxemia During Induction
Time frame: After starting induction, up to 30 minutes.
The Global Tolerance for Bronchoscopy
Time frame: After recovery from sedation, up to 120 minutes
The Cooperation of Patients From the View of Bronchoscopists
Time frame: After recovery from sedation, up to 120 minutes
Hypotension During Bronchoscopic Sedation
Time frame: After starting sedation, up to 120 minutes.
Bradycardia During Bronchoscopic Sedation
Time frame: After starting sedation, up to 120 minutes.
Procedure Time and Recovery Time
Time frame: After starting bronchoscopy, up to 120 minutes.

Results and safety

Results posted to the registry on 9 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexmedetomidine Arm	25	25
Propofol Arm	25	25

Primary outcome: Hypoxemia During Maintenance

Time frame: After starting bronchoscopy, up to 120 minutes. Count of participants. Unit: Participants

Measure	Dexmedetomidine Arm n = 25	Propofol Arm n = 25
Value	8	14

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: After subjects recovered from sedation, up to 30 minutes.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexmedetomidine Arm	9 of 25 (36%)	16 of 25 (64%)	0 of 25
Propofol Arm	17 of 25 (68%)	18 of 25 (72%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23638141Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.
Background: PubMed 22132138Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.
Background: PubMed 28819181Lin TY, Fang YF, Huang SH, Wang TY, Kuo CH, Wu HT, Kuo HP, Lo YL. Capnography monitoring the hypoventilation during the induction of bronchoscopic sedation: A randomized controlled trial. Sci Rep. 2017 Aug 17;7(1):8685. doi: 10.1038/s41598-017-09082-8.
Background: PubMed 22174346Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.
Results publication: PubMed 33693047Lin TY, Huang YC, Kuo CH, Chung FT, Lin YT, Wang TY, Lin SM, Lo YL. Dexmedetomidine sedation for endobronchial ultrasound-guided transbronchial needle aspiration, a randomised controlled trial. ERJ Open Res. 2020 Nov 10;6(4):00064-2020. doi: 10.1183/23120541.00064-2020. eCollection 2020 Oct.
Individual participant dataSharing planned: Undecided

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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.

Ting-Yu Lin, M.D. principal investigator

Chang Gung Memorial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine arm and Propofol arm in people with Bronchoscopy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 1 inclusion and 10 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 9 Sep 2021. 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 Taiwan. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hypoxemia During Maintenance (time frame: After starting bronchoscopy, up to 120 minutes). 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 NCT03521505, which also lists 5 linked publications.

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 9 Sep 2021.