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

NCT02157818 | Completed DMC

• 1 other identifier: dex512
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• 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).

Conditions

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Outcome Measures

Primary Outcomes (1)

• The number of Desaturation events

  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 Outcomes (7)

• RSS score

  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

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

• Endoscopist satisfaction

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

• Patient satisfaction

  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

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

Study Arms (2)

midazolam

ACTIVE COMPARATOR

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

Dexmedetomidine

EXPERIMENTAL

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

Interventions

midazolam DRUG

midazolam

Dexmedetomidine DRUG

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-799, South Korea

Location

Related Publications (1)

• Kim J, Choi SM, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Lee J. Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):534-540. doi: 10.1097/EJA.0000000000001370.

  PMID: 33122573 DERIVED

MeSH Terms

Interventions

Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

KR (1)