Effects of nebulized dexmedetomidine on lung function in COPD patients

Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease

This study is testing whether using a nebulized form of dexmedetomidine can help improve lung function in COPD patients who are about to have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing)
• Trial ID: NCT06207331 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of nebulized dexmedetomidine on lung function in patients with chronic obstructive pulmonary disease (COPD) who are scheduled for elective surgery. It aims to evaluate whether this non-invasive method can provide lung protection and improve respiratory function compared to traditional intravenous administration. Using portable pulmonary function instruments, the study will monitor changes in lung function in awake patients, focusing on safety and comfort. The research seeks to address the gap in knowledge regarding the effects of dexmedetomidine in non-mechanically ventilated patients.

Who should consider this trial

Good fit: Ideal candidates are patients aged 40 to 80 with diagnosed COPD scheduled for elective surgery and who can cooperate with the study.

Not a fit: Patients with obesity, severe hypertension, recent myocardial infarction, or uncontrolled asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance lung function and reduce postoperative complications in COPD patients undergoing surgery.

How similar studies have performed: Previous studies have shown positive effects of dexmedetomidine on lung function in mechanically ventilated patients, but this approach in awake patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with diagnosed COPD who are scheduled to undergo elective surgery (FEV1/FVC ratio\< 0.70)
2. Patients with mild, moderate, and severe COPD (FEV1≥30% predicted)
3. Age ≥ 40 years old, ≤ 80 years old
4. American Society of Anesthesiologists (ASA) Physical Situation Grading I-III
5. Able to cooperate with the experiment, voluntarily participate and be able to understand and sign the informed consent form

Exclusion Criteria:

1. Obese patients (BMI\>28 kg/m2)
2. Patients with grade 3 hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
3. Patients with myocardial infarction and shock in the past 3 months
4. Patients with unstable angina pectoris with NYHA heart function grade III or IV in the last 4 weeks
5. Tachycardia (heart rate \>120 beats/min), bradycardia (heart rate \<45 beats/min), and degree II or III atrioventricular block
6. Patients with severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis, thoracic malformation, pneumothorax, hemothorax, giant pulmonary bulla, and massive hemoptysis in the last 4 weeks
7. Pulmonary artery pressure ≥60 mmHg
8. Patients with Child B or C liver function
9. Patients with stage 4 or 5 chronic kidney disease
10. Patients with hyperthyroidism and pheochromocytoma
11. Patients with seizures requiring medication
12. Pregnant women
13. Patients with tympanic membrane perforation
14. Patients allergic to dexmedetomidine;
15. For any reason, it is not possible to cooperate with the study or the researcher considers it inappropriate to be included in this experiment

Where this trial is running

Chongqing, Chongqing

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)

Study contacts

• Principal investigator: Bing Chen, PhD — The Second Affiliated Hospital of Chongqing Medical University
• Study coordinator: He Huang, PhD

Conditions Respiratory Function Tests; Chronic Obstructive Pulmonary Disease; Dexmedetomidine