NCT04211298
Unknown
Phase 4
Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Sedation Complication
- Sponsor
- Rabin Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- number of de-saturation events
- Last Updated
- 6 years ago
Overview
Brief Summary
The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.
The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications
Investigators
Mordechai Kremer
Head of the pulmonary division
Rabin Medical Center
Eligibility Criteria
Inclusion Criteria
- •All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center
Exclusion Criteria
- •known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine \> 2 mg/dL) or hepatic impairment (elevated liver enzymes \> 2 times normal), haemodynamic instability (bradycardia with HR \< 50 bpm or hypotension with SBP \< 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III
Arms & Interventions
Propofol
Propofol will be used for sedation during bronchoscopy
Intervention: Propofol
Dexmedetomidine
Dexmedetomidine will be used for sedation during bronchoscopy
Intervention: Dexmedetomidine
Outcomes
Primary Outcomes
number of de-saturation events
Time Frame: During the procedure
Number of events during bronchoscopy when saturation level decreased under 90%
Oxygen saturation time < 90%
Time Frame: During the procedure
Total time during the procedure that the oxygen saturation was under 90%
Study Sites (1)
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