Trial Outcomes & Findings for Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (NCT NCT03521505)

NCT ID: NCT03521505

Last Updated: 2021-09-09

Results Overview

The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during maintenance of Bronchoscopic sedation

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: After starting bronchoscopy, up to 120 minutes
• Results posted on: 2021-09-09

Participant Flow

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.

50 subjects met inclusion criteria and were randomized to treatment.

Participant milestones

Measure	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	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.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Baseline characteristics by cohort

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 14.1 • n=93 Participants	59.4 years STANDARD_DEVIATION 12.2 • n=4 Participants	59.5 years STANDARD_DEVIATION 12.6 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	12 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Race/Ethnicity, Customized Asian	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Body mass index	23.6 kg/m^2 STANDARD_DEVIATION 3.9 • n=93 Participants	23.6 kg/m^2 STANDARD_DEVIATION 3.8 • n=4 Participants	23.6 kg/m^2 STANDARD_DEVIATION 3.8 • n=27 Participants
American Society of Anaesthesiologists physical status	3 units on a scale n=93 Participants	3 units on a scale n=4 Participants	3 units on a scale n=27 Participants
Mallampati score	2 units on a scale n=93 Participants	2 units on a scale n=4 Participants	2 units on a scale n=27 Participants

PRIMARY outcome

Timeframe: After starting bronchoscopy, up to 120 minutes

The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during maintenance of Bronchoscopic sedation

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
Hypoxemia During Maintenance	8 Participants	14 Participants

SECONDARY outcome

Timeframe: After starting induction, up to 30 minutes.

The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during induction of bronchoscopic sedation

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
Hypoxemia During Induction	1 Participants	2 Participants

SECONDARY outcome

Timeframe: After recovery from sedation, up to 120 minutes

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

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
The Global Tolerance for Bronchoscopy	12.5 units on a scale Interval 0.0 to 96.0	0 units on a scale Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: After recovery from sedation, up to 120 minutes

The Cooperation of Patients will be evaluated by 100-mm visual analogue scale (VAS, 0: well cooperation, 100: worst cooperation) after recovery.

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
The Cooperation of Patients From the View of Bronchoscopists	14 units on a scale Interval 0.0 to 87.0	31 units on a scale Interval 1.0 to 70.0

SECONDARY outcome

Timeframe: After starting sedation, up to 120 minutes.

The percentage of patients with hypotension (mean arterial blood pressure (MAP) less than 65 mmHg with any duration.

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
Hypotension During Bronchoscopic Sedation	1 Participants	5 Participants

SECONDARY outcome

Timeframe: After starting sedation, up to 120 minutes.

The percentage of patients with bradycardia (heat beat per minute less than 60)

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
Bradycardia During Bronchoscopic Sedation	12 Participants	4 Participants

SECONDARY outcome

Timeframe: After starting bronchoscopy, up to 120 minutes.

The procedure time of bronchoscopy and recovery time from sedation to awake.

Outcome measures

Measure	Dexmedetomidine Arm n=25 Participants 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	Propofol Arm n=25 Participants 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.
Procedure Time and Recovery Time	30.0 minutes Standard Deviation 13.2	27.6 minutes Standard Deviation 8.6

Adverse Events

Dexmedetomidine Arm

Serious events: 9 serious events

Other events: 16 other events

Deaths: 0 deaths

Propofol Arm

Serious events: 17 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexmedetomidine Arm n=25 participants at risk 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	Propofol Arm n=25 participants at risk 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.
Cardiac disorders Hypotension	4.0% 1/25 • Number of events 1 • After subjects recovered from sedation, up to 30 minutes.	20.0% 5/25 • Number of events 5 • After subjects recovered from sedation, up to 30 minutes.
Respiratory, thoracic and mediastinal disorders Hypoxemia	32.0% 8/25 • Number of events 8 • After subjects recovered from sedation, up to 30 minutes.	56.0% 14/25 • Number of events 14 • After subjects recovered from sedation, up to 30 minutes.

Other adverse events

Measure	Dexmedetomidine Arm n=25 participants at risk 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	Propofol Arm n=25 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Sore throat	28.0% 7/25 • Number of events 7 • After subjects recovered from sedation, up to 30 minutes.	48.0% 12/25 • Number of events 17 • After subjects recovered from sedation, up to 30 minutes.
Respiratory, thoracic and mediastinal disorders Cough	36.0% 9/25 • Number of events 9 • After subjects recovered from sedation, up to 30 minutes.	64.0% 16/25 • Number of events 16 • After subjects recovered from sedation, up to 30 minutes.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/25 • After subjects recovered from sedation, up to 30 minutes.	12.0% 3/25 • Number of events 3 • After subjects recovered from sedation, up to 30 minutes.
Nervous system disorders Nausia	4.0% 1/25 • Number of events 1 • After subjects recovered from sedation, up to 30 minutes.	0.00% 0/25 • After subjects recovered from sedation, up to 30 minutes.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • After subjects recovered from sedation, up to 30 minutes.	24.0% 6/25 • Number of events 6 • After subjects recovered from sedation, up to 30 minutes.

Additional Information

Dr Ting-Yu Lin

Chang-Gung Memorial Hospital

Phone: 886 3281200

Email: yuebaoyuebao@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place