Dexmedetomidine Versus General Anesthesia on the Diagnosis of Endobronchial US-Guided Transbronchial Needle Aspiration

Not Applicable

Completed

• Conditions: Sedation; Dexmedetomidine; EBUS Guided Transbronchial Needle Aspiration
• Interventions: Procedure: general anesthesia; Procedure: dexmedetomidine

• Registration Number: NCT05781035
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-03-23
• Study Start: 2023-04-01
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia group	general anesthesia	-
dexmedetomidine group	dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of Endobronchial ultrasound -guided transbronchial needle aspiration	During procedure	The number of subjects in whom Endobronchial ultrasound -guided transbronchial needle aspiration provided a specific diagnosis will be assessed

Trial Locations

Locations (1)

Mohammad Fouad Algyar; 🇪🇬 Tanta, ElGharbiaa, Egypt