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

May 17, 2017 updated by: Jinwoo Lee, Seoul National University Hospital

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

  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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-799
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: midazolam
midazolam IV bolus 0.05ml/kg bolus in 1minute. rescue drug(Midazolam) 1 mg, IV boluses for double blinding setting, we use saline, 0.4 mcg/kg IV bolus in 10 minutes and 0.5 mcg/kg/h, as placebo.
Drug: midazolam
Experimental: Dexmedetomidine

Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.25-0.75 mcg/kg/h for RSS 3-5. Midazolam 1mg bolus IV pro re nata (PRN).

for double blinding setting, IV bolus 0.05ml/kg bolus in 1minute.
Drug: Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
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.
Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
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
Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room
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.
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
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
Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
Duration of desaturation (sec)
Time Frame: Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
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)
Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 1, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dex512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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