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NCT05781035 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05781035
Other study ID # 35719\9\22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date October 1, 2023

Study information
Verified date October 2023
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• dexmedetomidine
patients will recieve moderate sedation by dexmedetomidine as study group
• general anesthesia
general anesthesia with neuromuscular blockade under controlled ventilation as control group.

Locations
Country Name City State
Egypt Mohammad Fouad Algyar Tanta ElGharbiaa

Sponsors (1)
Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic yield of Endobronchial ultrasound -guided transbronchial needle aspiration The number of subjects in whom Endobronchial ultrasound -guided transbronchial needle aspiration provided a specific diagnosis will be assessed During procedure
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