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

NCT04211298 | Unknown Phase 4 FDA Drug

• 1 other identifier: 0312-19-RMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Sedation Complication

Outcome Measures

Primary Outcomes (2)

• number of de-saturation events

  Number of events during bronchoscopy when saturation level decreased under 90%

  During the procedure

• Oxygen saturation time < 90%

  Total time during the procedure that the oxygen saturation was under 90%

  During the procedure

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine will be used for sedation during bronchoscopy

Drug: Dexmedetomidine

Propofol

PLACEBO COMPARATOR

Propofol will be used for sedation during bronchoscopy

Drug: Propofol

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be used for sedation during bronchoscopy

Dexmedetomidine

Propofol DRUG

Propofol

Propofol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 35291989 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Barak Pertzov, MD

CONTACT

972548080196; pertzovb@gmail.com

Mordechai Kramer, MD

CONTACT

97239377224; Kremerm@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the pulmonary division

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 26, 2019
• Study Start: December 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: August 1, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)