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

NCT ID: NCT02157818

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

Brief Summary

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).

Conditions

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Interventions

midazolam

Intervention Type: DRUG

Dexmedetomidine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinwoo Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 33122573 (View on PubMed)

Other Identifiers

dex512

Identifier Type: -

Identifier Source: org_study_id