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A study to evaluate safety and efficacy of intranasal vs intravenous dexmedetomidine in patients undergoing ebus tbna

A randomised trial to compare the efficacy and safety of intranasal vs intravenous dexmedetomidine for procedural sedation during endobronchial ultrasound guided transbronchial needle aspiration. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105881
Enrollment
110
Registered
2026-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J985- Diseases of mediastinum, not elsewhere classified

Interventions

Intervention1: Intranasal Dexmedetomidine: Intranasal Dexmedetomidine as a bolus sedative given over 10 minutes via nasal atomizer Control Intervention1: Intravenous Dexmedetomidine: Intravenous Dexme

Sponsors

AIIMS Mangalagiri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years both male and female 2. Referred for EBUS-TBNA from mediastinal and/or hilar lymph nodes visible on thoracic CT scans 3. American Society of Anesthesiologists physical status I or II

Exclusion criteria

Exclusion criteria: 1. Patients with hemodynamic instability (hypotension, respiratory failure, arrhythmia, or recent acute coronary events) 2. Participants with baseline heart rate less than 50 beats per minute. 3. Any neuropsychiatric illness 4. Documented coagulopathy 5. Nasal obstruction, active rhinitis, sinusitis, and nasal polyposis 4. Known allergy to dexmedetomidine, midazolam, fentanyl, or lignocaine 5. Pregnant women or breastfeeding individuals 6. Patients undergoing a repeat EBUS-TBNA procedure 7. Failure to provide informed consent

Design outcomes

Primary

MeasureTime frame
1. Patient comfort VAS Timepoint: One Hour after the procedure

Secondary

MeasureTime frame
1. Physician comfort VAS 2. Total cumulative rescue dose of fentanyl ( g/kg) & midazolam (mg/kg) administered 3. Safety outcomes proportion of subjects developing hypotension, bradycardia, desaturation, airway intervention, or need to stop dexmedetomidine infusionTimepoint: Five minutes after the procedure

Countries

India

Contacts

Public ContactSwetha R

AIIMS Mangalagiri

ravindra@aiimsmangalagiri.edu.in8098354127

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026