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

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

Study Overview

• Status: Unknown
• Conditions: Sedation Complication
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Barak Pertzov, MD; Phone Number: 972548080196; Email: pertzovb@gmail.com
• Study Contact Backup: Name: Mordechai Kramer, MD; Phone Number: 97239377224; Email: Kremerm@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center
    • Principal Investigator: Mordechai R Kramer, MD
    • Contact: Mordechai R Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; Dexmedetomidine will be used for sedation during bronchoscopy	Drug: Dexmedetomidine; Dexmedetomidine will be used for sedation during bronchoscopy
Placebo Comparator: Propofol; Propofol will be used for sedation during bronchoscopy	Drug: Propofol; Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): May 30, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 0312-19-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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