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

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

Sponsors

Lead Sponsor: Rabin Medical Center

Source Rabin Medical Center
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

Overall Status Recruiting
Start Date December 1, 2019
Completion Date August 1, 2020
Primary Completion Date May 30, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
number of de-saturation events During the procedure
Oxygen saturation time < 90% During the procedure
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexmedetomidine

Description: Dexmedetomidine will be used for sedation during bronchoscopy

Arm Group Label: Dexmedetomidine

Intervention Type: Drug

Intervention Name: Propofol

Description: Propofol

Arm Group Label: Propofol

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Barak Pertzov, MD

Phone: 972548080196

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Rabin Medical Center Mordechai R Kramer, MD Mordechai R Kramer, MD Principal Investigator
Location Countries

Israel

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rabin Medical Center

Investigator Full Name: Mordechai Kremer

Investigator Title: Head of the pulmonary division

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Dexmedetomidine

Type: Active Comparator

Description: Dexmedetomidine will be used for sedation during bronchoscopy

Label: Propofol

Type: Placebo Comparator

Description: Propofol will be used for sedation during bronchoscopy

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomised controlled trial

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov