Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research
Chandigarh, 160023, India
NCT Number: NCT02713191
The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound
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Notify Me18 year–99 year
All sexes
Interventional
Phase 2 / Phase 3
Chandigarh, 160023, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Midazolam 2 mg as slow intravenous bolus immediately prior to procedure
100 mL saline infusion over 10-15 minutes immediately prior to procedure
Rescue boluses of 0.5 mg midazolam, if needed during procedure
1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Time frame: Immediately after endobronchial ultrasound procedure
Time frame: From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial
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