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Completed

NCT Number: NCT02157818

A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration

1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated status for patients.

* However, especially in bronchoscope procedure, continuous monitoring of oxygen saturation is needed to prevent hypoxia due to respiratory distress induced by benzodiazepine. * A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less adverse effect of respiratory distress compared to previous agents, was introduced. 2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).

* Double blind randomized trial * Primary outcome: The number and duration of desaturation, volume of sedative, any use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and hypertension, tachycardia, any need for mandible support or manual ventilation, and any need for intubation (for safety).

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Key information

Conditions

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-799, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who visit Seoul National University Hospital between 2014.04 - 2015.04
  • Patients who undergo EBUS-TBNA during the period
  • Aged between 18-75
  • Patients who meet the criteria of American Society of Anesthesiologists (ASA) physical status classification I-III

Exclusion criteria

  • American Society of Anesthesiologists (ASA) physical status classification >3
  • Have glomerular filtration rate (GFR) less than 15ml/min 1.73m2 or undergoing hemodialysis
  • End stage liver disease.
  • Impaired ventricular functions (EF <30%)
  • Patients with baseline oxygen desaturation (resting SpO2 <90%)
  • Asthma or chronic obstructive pulmonary disease or a forced expiratory volume in 1 s (FEV1)of < 1.0 liter
  • Bradycardia [baseline heart rate (HR)< 60 beats/min]
  • Hypotension [baseline systolic arterial pressure (SAP) < 100 mm Hg]
  • Pregnant state
  • Those intolerant or with an allergy to the study drug
  • those unable or who refused to give informed consent

Treatment and study plan

midazolam

Drug

Dexmedetomidine

Drug

Primary outcomes

  1. The number of Desaturation events

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

    The number of desaturation (SpO2 <90% for more than 5 seconds) events

Secondary outcomes

  1. RSS score

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

    RSS score: at the beginning of the procedure, minimum RSS score, every 5 minute

  2. Total dose of intratracheal lidocaine instillation

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

    Cumulative dose of lidocaine administered at bronchus by the endoscopist for local anesthesia by topical instillation.

    Topical lidocaine instillation is performed in both the two arms for procedure as routine bronchoscopy.

  3. Endoscopist satisfaction

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room

    Endoscopist global satisfaction score based on a VAS score

  4. Patient satisfaction

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

    Global patient satisfaction associated with the procedure. Score based on a VAS score measured before the patients leave the bronchoscopy room.

  5. Use of rescue midazolam

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

    Use of rescue midazolam, total dose

  6. Duration of desaturation (sec)

    Time frame: Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours

  7. Hemodynamic adverse event

    Time frame: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

    Hypotension ( < mean BP 60 mmHg) Bradycardia ( < 50 bpm)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2014
Registry last updated
May 19, 2017

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.