Endobronchial Ultrasound Clinical Trial
Official title:
Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial
Verified date | February 2017 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound
Status | Completed |
Enrollment | 197 |
Est. completion date | February 1, 2017 |
Est. primary completion date | February 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
India | Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale | Immediately after endobronchial ultrasound procedure | ||
Secondary | 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 |
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