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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06207331
Enrollment
6
Registered
2024-01-17
Start date
2023-10-28
Completion date
2024-06-30
Last updated
2025-05-31

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

Conditions

Chronic Obstructive Pulmonary Disease, Dexmedetomidine, Respiratory Function Tests

Brief summary

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.

Detailed description

Chronic obstructive pulmonary disease (COPD) is a common respiratory disease that seriously endangers the physical and mental health of patients. Surgical patients with COPD will increase the risk of postoperative pulmonary complications and the risk of complications of extrapulmonary organs such as heart and kidney, and lead to prolonged hospital stay, increased medical costs, and increased perioperative mortality. Therefore, it is necessary to explore drugs with lung protection effects to improve the perioperative safety of COPD patients. Dexmedetomidine (Dex) is a new type of highly selective α2-adrenergic receptor agonist, which has the effects of sedative-hypnotic, anti-inflammatory, stress reduction, hemodynamic stabilization, analgesia, and organ protection, and has little inhibitory effect on respiratory function. In recent years, studies have found that dexmedetomidine may have the effect of improving lung function. In addition, human studies have found that intravenous infusion of dexmedetomidine (loading dose 0.5 to 1 μg/kg or 0.5 to 0.7 μg/kg/hour) can reduce inflammation levels, improve oxidative stress, reduce plateau pressure, peak airway pressure, airway resistance, and improve lung compliance, thereby improving oxygenation and postoperative pulmonary complications, and promoting patient recovery. In obese patients undergoing laparoscopic gastric reduction, intraoperative intravenous dexmedetomidine infusion (loading dose of 1 μg/kg, followed by 1 μg/kg/hour) improves lung compliance and oxygenation. One study found that intraoperative intravenous infusion of dexmedetomidine (loading dose of 1 μg/kg, followed by 0.5 μg/kg/hour) increased forced expiratory volume in one second and improved postoperative oxygenation on days 1 and 2 after one-lung ventilation. Another study found that nebulized inhalation of 0.5 μg/kg, 1 μg/kg, and 2 μg/kg dexmedetomidine in one-lung ventilation for thoracic surgery improved lung compliance and oxygenation. These 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, has limited effect, high safety, fewer side effects, and higher 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.

Interventions

Participants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline.

Participants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline.

DRUGSaline

Participants inhale atomized 2 ml 0.9% saline.

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FVC10 minutes and 30 minutes after administration of nebulized drugsForced vital capacity

Secondary

MeasureTime frameDescription
FEV1/FVC%10 minutes and 30 minutes after administration of nebulized drugsForced expiratory volume in one second/Forced vital capacity
MMEF10 minutes and 30 minutes after administration of nebulized drugsmaximal mid-expiratory flow curve
PEF10 minutes and 30 minutes after administration of nebulized drugsPeak expiratory flow
BEV10 minutes and 30 minutes after administration of nebulized drugsBack-extrapolation volume
FET10 minutes and 30 minutes after administration of nebulized drugsForced expiratory time
VC10 minutes and 30 minutes after administration of nebulized drugsVital capacity
FEV1/VC10 minutes and 30 minutes after administration of nebulized drugsForced expiratory volume in one second/vital capacity
FEF25%,FEF50%,FEF75%,10 minutes and 30 minutes after administration of nebulized drugsforced expiratory flow at 25%, 50%, and 75% of FVC exhaled
FEV110 minutes and 30 minutes after administration of nebulized drugsForced expiratory volume in one second
FIVC10 minutes and 30 minutes after administration of nebulized drugsforced inspiratory vital capacity
FIF25, FIF50, FIF7510 minutes and 30 minutes after administration of nebulized drugsforced inspiratory flow at 25%, 50%, and 75% of FIVC
FIV110 minutes and 30 minutes after administration of nebulized drugsforced inspiratory volume in 1 second
MVV10 minutes and 30 minutes after administration of nebulized drugsmaximal ventilatory volume
Richmond Agitation-Sedation Scale (RASS)10 minutes and 30 minutes after administration of nebulized drugsRASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 \[combative\]), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5).
heart rate10 minutes and 30 minutes after administration of nebulized drugsheart rate (beat per min)
Systolic and diastolic blood pressures10 minutes and 30 minutes after administration of nebulized drugsSystolic and diastolic blood pressures (mmHg)
SPO210 minutes and 30 minutes after administration of nebulized drugsPulse oximetry (SpO2)
PIF10 minutes and 30 minutes after administration of nebulized drugspeak inspiratory flow

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026