Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration
Condition: Bronchoscopy
Intervention: Dexmedetomidine arm; Propofol arm
Intervention description: 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; 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.
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sedation; dexmedetomidine; brain perfusion; bronchoscopy

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.
    

Eligibility criteria:

        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