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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine arm | Experimental | Dexmedetomidine will be administrated for sedation of EBUS-TBNA |
|
| Propofol arm | Active Comparator | Propofol will be administrated for sedation of EBUS-TBNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine arm | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia During Maintenance | The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during maintenance of Bronchoscopic sedation | After starting bronchoscopy, up to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia During Induction | The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during induction of bronchoscopic sedation | After starting induction, up to 30 minutes. |
| The Global Tolerance for Bronchoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting-Yu Lin, M.D. | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Medicine, Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23638141 | Background | 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. | |
| 22132138 | Background |
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50 subjects met inclusion criteria and were randomized to treatment.
Participants were recruited from chest physicians referral at a medical center between and . The first participant was enrolled in May 2018 and the last participant was enrolled in January 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine Arm | Dexmedetomidine will be administrated for sedation of EBUS-TBNA Dexmedetomidine arm: 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 |
| FG001 | Propofol Arm | Propofol will be administrated for sedation of EBUS-TBNA Propofol arm: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine Arm | Dexmedetomidine will be administrated for sedation of EBUS-TBNA Dexmedetomidine arm: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hypoxemia During Maintenance | The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during maintenance of Bronchoscopic sedation | Posted | Count of Participants | Participants | After starting bronchoscopy, up to 120 minutes |
|
After subjects recovered from sedation, up to 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine Arm | Dexmedetomidine will be administrated for sedation of EBUS-TBNA Dexmedetomidine arm: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ting-Yu Lin | Chang-Gung Memorial Hospital | 886 3281200 | 8467 | yuebaoyuebao@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2017 | Aug 15, 2021 | Prot_SAP_001.pdf |
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|
| Propofol arm | Drug | 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. |
|
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
| 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. | 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. | After starting sedation, up to 120 minutes. |
| Bradycardia During Bronchoscopic Sedation | The percentage of patients with bradycardia (heat beat per minute less than 60) | After starting sedation, up to 120 minutes. |
| Procedure Time and Recovery Time | The procedure time of bronchoscopy and recovery time from sedation to awake. | After starting bronchoscopy, up to 120 minutes. |
| 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. |
| 28819181 | Background | 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. |
| 22174346 | Background | 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. |
| 33693047 | Result | 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. |
| BG001 | Propofol Arm | Propofol will be administrated for sedation of EBUS-TBNA Propofol arm: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anaesthesiologists physical status | The American Society of Anesthesiologists physical status classification system is a grading system for assessing the fitness of patients before surgery. A sixth category was later added. The higher grade, the poor physical status.
| Median | Full Range | units on a scale |
|
| Mallampati score | Mallampati score comprises a visual assessment of the distance from the tongue base to the roof of the mouth, and therefore the amount of space in which there is to work. There are 4 scores. The higher score represents narrower space of upper airway. Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible. | Median | Full Range | units on a scale |
|
| OG001 | Propofol Arm | Propofol will be administrated for sedation of EBUS-TBNA Propofol arm: 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. |
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| Secondary | Hypoxemia During Induction | The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during induction of bronchoscopic sedation | Posted | Count of Participants | Participants | After starting induction, up to 30 minutes. |
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|
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| Secondary | 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 | Posted | Median | Full Range | units on a scale | After recovery from sedation, up to 120 minutes |
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|
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| Secondary | 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. | Posted | Median | Full Range | units on a scale | After recovery from sedation, up to 120 minutes |
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| Secondary | Hypotension During Bronchoscopic Sedation | The percentage of patients with hypotension (mean arterial blood pressure (MAP) less than 65 mmHg with any duration. | Posted | Count of Participants | Participants | After starting sedation, up to 120 minutes. |
|
|
|
| Secondary | Bradycardia During Bronchoscopic Sedation | The percentage of patients with bradycardia (heat beat per minute less than 60) | Posted | Count of Participants | Participants | After starting sedation, up to 120 minutes. |
|
|
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| Secondary | Procedure Time and Recovery Time | The procedure time of bronchoscopy and recovery time from sedation to awake. | Posted | Mean | Standard Deviation | minutes | After starting bronchoscopy, up to 120 minutes. |
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| 0 |
| 25 |
| 9 |
| 25 |
| 16 |
| 25 |
| EG001 | Propofol Arm | Propofol will be administrated for sedation of EBUS-TBNA Propofol arm: 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. | 0 | 25 | 17 | 25 | 18 | 25 |
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
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