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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Mean difference in depth of sedation during procedure as assessed by Ramsay scale(From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours)
• Mean difference in time taken to discharge patient from post-procedure recovery room(From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours)
• Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia(From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours)
• Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation(From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours)
• Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale(Immediately after endobronchial ultrasound procedure)