NCT02713191

Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound

Detailed description

Benzodiazepines, opioids, and propofol are currently used alone or in combination for achieving sedation during endobronchial ultrasound and other bronchoscopic procedures. However, all these agents carry a risk of respiratory depression. Dexmedetomidine, a highly selective adrenergic alpha-2 agonist, has sedative and analgesic properties but does not cause respiratory depression. This study aims to compare efficacy and safety of dexmedetomidine as a sedative to midazolam in patients with hilar/mediastinal lymphadenopathy undergoing convex-probe endobronchial ultrasonography on day care basis. Patients will be randomized to receive either dexmedetomidine plus fentanyl or midazolam plus fentanyl prior to procedure, followed by dexmedetomidine or saline infusion respectively during the procedure. Ramsay sedation score of two will be targeted, failing which patients in both groups will receive midazolam bolus on as-needed basis. Bronchoscopist will remain blinded to group allocation. Patients will be monitored for sedation, oxygenation and hemodynamic parameters throughout. Need for additional midazolam, sedative efficacy, frequency of adverse respiratory and hemodynamic events, and bronchoscopist and patient satisfaction with the procedure will be compared between the two groups.

Conditions

• Conscious Sedation During Procedure
• Endobronchial Ultrasound

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-03-18
• Last updated: 2017-02-17

Locations

1 site across 1 country: India