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NCT Number: NCT03521505

Dexmedetomidine 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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Hypoxemia During Induction

    Time frame: After starting induction, up to 30 minutes.

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

  2. The Global Tolerance for Bronchoscopy

    Time frame: 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

  3. The Cooperation of Patients From the View of Bronchoscopists

    Time frame: 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.

  4. Hypotension During Bronchoscopic Sedation

    Time frame: 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.

  5. Bradycardia During Bronchoscopic Sedation

    Time frame: After starting sedation, up to 120 minutes.

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

  6. Procedure Time and Recovery Time

    Time frame: After starting bronchoscopy, up to 120 minutes.

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 11, 2018
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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