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Clinical Trials/NCT05781035
NCT05781035
Completed
Not Applicable

Moderate Sedation by Dexmedetomidine Versus General Anesthesia on the Diagnostic Yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: A Randomized Controlled Study

Kafrelsheikh University1 site in 1 country70 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedation
Sponsor
Kafrelsheikh University
Enrollment
70
Locations
1
Primary Endpoint
Diagnostic yield of Endobronchial ultrasound -guided transbronchial needle aspiration
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to compare dexmedetomidine as moderate sedation versus general anathesia on the diagnostic yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Detailed Description

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (EBUS-TBNA) has emerged as a highly effective, minimally invasive technique for sampling peribronchial, mediastinal, and lung masses for pathologic examination with low rate of complications, and costs. Dexmedetomidine, is a high-affinity adrenergic agonist of the alpha 2 receptor, is a potential alternative sedative. The use of dexmedetomidine does not lead to respiratory depression, or to a decline in cognitive skills or patient cooperation. This is because dexmedetomidine acts on the alpha-2 receptors in the locus coeruleus, in contrast to other sedatives (midazolam and propofol) which act on GABA receptors/cerebral cortex.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Fouad Algyar

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Kafrelsheikh University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status classification II or III a requiring EBUS-TBNA based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes (LNs) or masses or requiring EBUS-TBNA for mediastinal staging of lung cancer.

Exclusion Criteria

  • Suspected need for additional procedures other than EBUS-TBNA during planned bronchoscopy (e.g., need for navigational bronchoscopy, endobronchial biopsies, and therapeutic bronchoscopy)
  • body mass index \> 35 kg/m2
  • allergies to any of the involved sedatives or anesthetic agents
  • comorbidities contraindicating the EBUS procedure
  • pregnancy

Outcomes

Primary Outcomes

Diagnostic yield of Endobronchial ultrasound -guided transbronchial needle aspiration

Time Frame: During procedure

The number of subjects in whom Endobronchial ultrasound -guided transbronchial needle aspiration provided a specific diagnosis will be assessed

Study Sites (1)

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