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

NCT ID: NCT05781035

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-10-01

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.

Conditions

Sedation; Dexmedetomidine; EBUS Guided Transbronchial Needle Aspiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dexmedetomidine group

Group Type: ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type: PROCEDURE

patients will recieve moderate sedation by dexmedetomidine as study group

general anesthesia group

Group Type: ACTIVE_COMPARATOR

general anesthesia

Intervention Type: PROCEDURE

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

Interventions

dexmedetomidine

patients will recieve moderate sedation by dexmedetomidine as study group

Intervention Type: PROCEDURE

general anesthesia

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fouad Algyar

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed S Torky

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Chest Department , Faculty of Medicine, Tanta University

Locations

Mohammad Fouad Algyar

Tanta, ElGharbiaa, Egypt

Countries

Egypt

Other Identifiers

35719\9\22

Identifier Type: -

Identifier Source: org_study_id