Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

February 1, 2017

Study Completion Date

February 1, 2017

Conditions
Conscious Sedation During ProcedureEndobronchial Ultrasound
Interventions
DRUG

Dexmedetomidine

Dexmedetomidine 1µg/Kg in 100 mL saline intravenously over 10-15 minutes immediately prior to procedure, followed by Dexmedetomidine infusion at 0.6 µg/kg/hour as maintenance dose during entire procedure

DRUG

Midazolam bolus

Midazolam 2 mg as slow intravenous bolus immediately prior to procedure

OTHER

Saline placebo

100 mL saline infusion over 10-15 minutes immediately prior to procedure

DRUG

Rescue midazolam

Rescue boluses of 0.5 mg midazolam, if needed during procedure

DRUG

Fentanyl

1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure

Trial Locations (1)

160023

Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT02713191 - Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound | Biotech Hunter | Biotech Hunter