Clinical trial

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

Name
2023.134
Description
Studies have shown that intravenous infusion and nebulized dexmedetomidine can improve lung function in mechanically ventilated patients, including those with preoperative COPD, exerting lung protection. However, these studies are based on mechanical ventilation patients under general anesthesia, and more intuitive research is needed on whether dexmedetomidine can also exercise pulmonary precaution in awake patients. Pulmonary function monitoring is the most direct way to evaluate changes in lung function in awake patients. Portable pulmonary function machines can assess lung function in a variety of settings. In addition, compared with intravenous administration, nebulized inhalation administration directly acts on the mucosa of the respiratory tract, does not involve invasive operations, and has higher safety and comfort. Therefore, this study intends to use portable pulmonary function instruments and non-invasive ambulatory respiratory monitors to evaluate the effect of nebulized dexmedetomidine on lung function in COPD patients to guide the perioperative management of COPD patients.
Trial arms
Trial start
2023-10-28
Estimated PCD
2025-10-31
Trial end
2025-12-31
Status
Recruiting
Treatment
Dexmedetomidine 0.5 μg/kg
Participants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
Arms:
Dexmedetomidine 0.5 μg/kg
Other names:
Dexmedetomidine Hydrochloride
Dexmedetomidine 1 μg/kg
Participants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
Arms:
Dexmedetomidine 1 μg/kg
Other names:
Dexmedetomidine Hydrochloride
Saline
Participants inhale atomized 2 ml 0.9% saline.
Arms:
Placebo
Other names:
Normal Saline
Size
96
Primary endpoint
FVC
10 minutes and 30 minutes after administration of nebulized drugs
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}
Updated at
2024-03-13

1 organization

1 product

1 drug

3 indications

Indication
Dexmedetomidine