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

NCT05781035 | Completed

• 1 other identifier: 35719\9\22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Sedation; Dexmedetomidine; EBUS Guided Transbronchial Needle Aspiration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

Procedure: dexmedetomidine

general anesthesia group

ACTIVE COMPARATOR

Procedure: general anesthesia

Interventions

dexmedetomidine PROCEDURE

patients will recieve moderate sedation by dexmedetomidine as study group

dexmedetomidine group

general anesthesia PROCEDURE

general anesthesia with neuromuscular blockade under controlled ventilation as control group.

general anesthesia group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Mohammad Fouad Algyar

Tanta, ElGharbiaa, 31511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Anesthesia, General

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mohamed S Torky

  Lecturer of Chest Department , Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 23, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)