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

Sponsor

Kafrelsheikh University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05781035

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sedation Dexmedetomidine EBUS Guided Transbronchial Needle Aspiration	Procedure: dexmedetomidine Procedure: general anesthesia	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexmedetomidine group	Procedure: dexmedetomidine patients will recieve moderate sedation by dexmedetomidine as study group
Active Comparator: general anesthesia group	Procedure: general anesthesia general anesthesia with neuromuscular blockade under controlled ventilation as control group.

Arm

Intervention/Treatment

Active Comparator: dexmedetomidine group

Procedure: dexmedetomidine

patients will recieve moderate sedation by dexmedetomidine as study group

Active Comparator: general anesthesia group

Procedure: general anesthesia

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohammad Fouad Algyar	Tanta	ElGharbiaa	Egypt	31511

Sponsors and Collaborators

Kafrelsheikh University

Investigators

Principal Investigator: Mohamed S Torky, Lecturer of Chest Department , Faculty of Medicine, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Fouad Algyar, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT05781035

Other Study ID Numbers:

35719\9\22

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dexmedetomidine

Study Results

No Results Posted as of Mar 23, 2023