Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial

Sedation Complication Clinical Trial

Official title:

Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211298
• Other study ID #: 0312-19-RMC
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2019
• Source: Rabin Medical Center
• Contact: Barak Pertzov, MD
• Phone: 972548080196
• Email: pertzovb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sedation Complication

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine will be used for sedation during bronchoscopy
• Propofol
Propofol

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of de-saturation events	Number of events during bronchoscopy when saturation level decreased under 90%	During the procedure
Primary	Oxygen saturation time < 90%	Total time during the procedure that the oxygen saturation was under 90%	During the procedure