Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 11, 2018

Primary Completion Date

January 22, 2020

Study Completion Date

January 22, 2020

Conditions
Bronchoscopy
Interventions
DRUG

Dexmedetomidine arm

Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5\~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3\~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 \< 90%) or hypotension (mean arterial pressure (MAP) \< 65 mmHg, or systolic blood pressure (SBP) \< 90 mmHg) in any duration

DRUG

Propofol arm

"5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3\~2.~Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 \< 90%) or hypotension (mean arterial pressure (MAP) \< 65 mmHg, or systolic blood pressure (SBP) \< 90 mmHg) in any duration."

Trial Locations (1)

33305

Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taoyuan District

All Listed Sponsors
lead

Chang Gung Memorial Hospital

OTHER

NCT03521505 - Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration | Biotech Hunter | Biotech Hunter