Conscious Sedation During Procedure, Endobronchial Ultrasound
Conditions
Keywords
Bronchoscopy, Sedation, Dexmedetomidine
Brief 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.
Interventions
DRUGDexmedetomidine
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
DRUGMidazolam bolus
Midazolam 2 mg as slow intravenous bolus immediately prior to procedure
OTHERSaline placebo
100 mL saline infusion over 10-15 minutes immediately prior to procedure
DRUGRescue midazolam
Rescue boluses of 0.5 mg midazolam, if needed during procedure
DRUGFentanyl
1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
India
Outcome results
None listed