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

• ClinicalTrials.gov Identifier: NCT04211298
• Recruitment Status: Unknown
• First Posted: December 26, 2019
• Last Update Posted: December 26, 2019
• Sponsor: Rabin Medical Center
• Information provided by (Responsible Party): Mordechai Kremer, Rabin Medical Center

Tracking Information

• First Submitted Date: December 24, 2019
• First Posted Date: December 26, 2019
• Last Update Posted Date: December 26, 2019
• Actual Study Start Date: December 1, 2019
• Estimated Primary Completion Date: May 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 24, 2019)

• 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%

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
• Official Title: Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised controlled trial

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Sedation Complication

Intervention

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

Study Arms

• Active Comparator: Dexmedetomidine
  Dexmedetomidine will be used for sedation during bronchoscopy
  Intervention: Drug: Dexmedetomidine
• Placebo Comparator: Propofol
  Propofol will be used for sedation during bronchoscopy
  Intervention: Drug: Propofol

• Publications *: Pertzov B, Krasulya B, Azem K, Shostak Y, Izhakian S, Rosengarten D, Kharchenko S, Kramer MR. Dexmedetomidine versus propofol sedation in flexible bronchoscopy: a randomized controlled trial. BMC Pulm Med. 2022 Mar 15;22(1):87. doi: 10.1186/s12890-022-01880-9.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 24, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2020
• Estimated Primary Completion Date: May 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT04211298
• Other Study ID Numbers: 0312-19-RMC
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mordechai Kremer, Rabin Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Rabin Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rabin Medical Center
• Verification Date: December 2019