Bronchoscopy
Conditions
Keywords
Sedation, dexmedetomidine, brain perfusion, bronchoscopy
Brief summary
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.
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.
Interventions
DRUGDexmedetomidine 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
DRUGPropofol 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective bronchoscopy and sedation
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia During Maintenance | After starting bronchoscopy, up to 120 minutes | The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during maintenance of Bronchoscopic sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Global Tolerance for Bronchoscopy | 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 |
| The Cooperation of Patients From the View of Bronchoscopists | 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. |
| Hypoxemia During Induction | After starting induction, up to 30 minutes. | The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during induction of bronchoscopic sedation |
| Bradycardia During Bronchoscopic Sedation | After starting sedation, up to 120 minutes. | The percentage of patients with bradycardia (heat beat per minute less than 60) |
| Procedure Time and Recovery Time | After starting bronchoscopy, up to 120 minutes. | The procedure time of bronchoscopy and recovery time from sedation to awake. |
| Hypotension During Bronchoscopic Sedation | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
50 subjects met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Propofol Arm | Total | Dexmedetomidine Arm |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 12.2 | 59.5 years STANDARD_DEVIATION 12.6 | 59.7 years STANDARD_DEVIATION 14.1 |
| American Society of Anaesthesiologists physical status | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Body mass index | 23.6 kg/m^2 STANDARD_DEVIATION 3.8 | 23.6 kg/m^2 STANDARD_DEVIATION 3.8 | 23.6 kg/m^2 STANDARD_DEVIATION 3.9 |
| Mallampati score | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Race/Ethnicity, Customized Asian | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 16 / 25 | 18 / 25 |
| serious Total, serious adverse events | 9 / 25 | 17 / 25 |
Outcome results
Primary
Hypoxemia During Maintenance
The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during maintenance of Bronchoscopic sedation
Time frame: After starting bronchoscopy, up to 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine Arm | Hypoxemia During Maintenance | 8 Participants |
| Propofol Arm | Hypoxemia During Maintenance | 14 Participants |
Secondary
Bradycardia During Bronchoscopic Sedation
The percentage of patients with bradycardia (heat beat per minute less than 60)
Time frame: After starting sedation, up to 120 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine Arm | Bradycardia During Bronchoscopic Sedation | 12 Participants |
| Propofol Arm | Bradycardia During Bronchoscopic Sedation | 4 Participants |
Secondary
Hypotension During Bronchoscopic Sedation
The percentage of patients with hypotension (mean arterial blood pressure (MAP) less than 65 mmHg with any duration.
Time frame: After starting sedation, up to 120 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine Arm | Hypotension During Bronchoscopic Sedation | 1 Participants |
| Propofol Arm | Hypotension During Bronchoscopic Sedation | 5 Participants |
Secondary
Hypoxemia During Induction
The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during induction of bronchoscopic sedation
Time frame: After starting induction, up to 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine Arm | Hypoxemia During Induction | 1 Participants |
| Propofol Arm | Hypoxemia During Induction | 2 Participants |
Secondary
Procedure Time and Recovery Time
The procedure time of bronchoscopy and recovery time from sedation to awake.
Time frame: After starting bronchoscopy, up to 120 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine Arm | Procedure Time and Recovery Time | 30.0 minutes | Standard Deviation 13.2 |
| Propofol Arm | Procedure Time and Recovery Time | 27.6 minutes | Standard Deviation 8.6 |
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.
Time frame: After recovery from sedation, up to 120 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine Arm | The Cooperation of Patients From the View of Bronchoscopists | 14 units on a scale |
| Propofol Arm | The Cooperation of Patients From the View of Bronchoscopists | 31 units on a scale |
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
Time frame: After recovery from sedation, up to 120 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine Arm | The Global Tolerance for Bronchoscopy | 12.5 units on a scale |
| Propofol Arm | The Global Tolerance for Bronchoscopy | 0 units on a scale |