Phase 4
N=50
Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration
Bronchoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03521505 ↗Enrolled (actual)
50
Serious AEs
52.0%
Results posted
Sep 2021
Primary outcome: Primary: Hypoxemia During Maintenance — 8; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine arm (Drug); Propofol arm (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoxemia During Maintenance |
8; 14 | — |
| SECONDARY Hypoxemia During Induction |
1; 2 | — |
| SECONDARY The Global Tolerance for Bronchoscopy |
12.5; 0 | — |
| SECONDARY The Cooperation of Patients From the View of Bronchoscopists |
14; 31 | — |
| SECONDARY Hypotension During Bronchoscopic Sedation |
1; 5 | — |
| SECONDARY Bradycardia During Bronchoscopic Sedation |
12; 4 | — |
| SECONDARY Procedure Time and Recovery Time |
30.0; 27.6 | — |
Summary
Preventing hypoxemia is one of the major goal of studies for bronchoscopic sedation. Dexmedetomidine is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. In the preset study, we evaluate the safety and feasibility of the Dexmedetomidine in the specific bronchoscopic procedure, endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing elective bronchoscopy and sedation
Exclusion Criteria
- Age less than 20 years
- American Society of Anaesthesiologists (ASA) physical status classification IV or V
- Mallampati score of 4
- Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
- Body mass index more than 42 in males or 35 in females
- Neurologic disorders or other conditions contributing to difficulty in assessing response
- Forced expiratory vital capacity (FVC) less than 15 ml/kg body weight, forced expiratory volume in one second (FEV1) less than 1000 ml, or FEV1/FVC less than 35%
- History of second or third degree atrioventricular block, heat rate less than 50 beat per minute or systolic blood pressure less than 90 mmHg
- Pregnancy
- Patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products
Data sourced from ClinicalTrials.gov (NCT03521505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.