Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

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

Detailed Description
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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.

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

Conditions
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Conscious Sedation During Procedure, Endobronchial Ultrasound

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam bolus
* Other: Saline placebo
* Drug: Rescue midazolam
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or more American Society of Anesthesiologists physical status I or II Presence of hilar and/or mediastinal lymph nodes on thoracic CT scan Exclusion Criteria: Known allergy to dexmedetomidine or midazolam or fentanyl Documented coagulopathy Pregnancy Hemodynamic instability (hypotension, arrhythmia, recent acute coronary event) Neuropsychiatric illness History of previous endobronchial ultrasound procedure Refusal to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure | Drug: Dexmedetomidine<br>* 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<br>Drug: Rescue midazolam<br>* Rescue boluses of 0.5 mg midazolam, if needed during procedure<br>Drug: Fentanyl<br>* 1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure<br>|
| Active Comparator: Midazolam<br>Midazolam + fentanyl before, and matching saline infusion during, procedure | Drug: Midazolam bolus<br>* Midazolam 2 mg as slow intravenous bolus immediately prior to procedure<br>Other: Saline placebo<br>* 100 mL saline infusion over 10-15 minutes immediately prior to procedure<br>Drug: Rescue midazolam<br>* Rescue boluses of 0.5 mg midazolam, if needed during procedure<br>Drug: Fentanyl<br>* 1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two |  | From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Sedation, Dexmedetomidine