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

Not Applicable

Completed

• Conditions: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
• Interventions: Drug: midazolam; Drug: Dexmedetomidine

• Registration Number: NCT02157818
• Lead Sponsor: Seoul National University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-01
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam	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.
Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
The number of Desaturation events	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 Outcome Measures

Name	Time	Method
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	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.
Duration of desaturation (sec)	Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours
RSS score	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
Endoscopist satisfaction	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 satisfaction	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.
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	Use of rescue midazolam, total dose
Hemodynamic adverse event	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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of