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

K

Kafrelsheikh University

Status

Completed

Conditions

EBUS Guided Transbronchial Needle Aspiration
Dexmedetomidine
Sedation

Treatments

Procedure: general anesthesia
Procedure: dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT05781035
35719\9\22

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

dexmedetomidine group
Active Comparator group
Treatment:
Procedure: dexmedetomidine
general anesthesia group
Active Comparator group
Treatment:
Procedure: general anesthesia

Trial contacts and locations

1

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Central trial contact

Mohammad F Algyar

Data sourced from clinicaltrials.gov

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