Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary DiseaseRespiratory Function TestsDexmedetomidine
- Interventions
- Registration Number
- NCT06207331
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Patients with diagnosed COPD who are scheduled to undergo elective surgery (FEV1/FVC ratio< 0.70)
- Patients with mild, moderate, and severe COPD (FEV1≥30% predicted)
- Age ≥ 40 years old, ≤ 80 years old
- American Society of Anesthesiologists (ASA) Physical Situation Grading I-III
- Able to cooperate with the experiment, voluntarily participate and be able to understand and sign the informed consent form
- Obese patients (BMI>28 kg/m2)
- Patients with grade 3 hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
- Patients with myocardial infarction and shock in the past 3 months
- Patients with unstable angina pectoris with NYHA heart function grade III or IV in the last 4 weeks
- Tachycardia (heart rate >120 beats/min), bradycardia (heart rate <45 beats/min), and degree II or III atrioventricular block
- 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
- Pulmonary artery pressure ≥60 mmHg
- Patients with Child B or C liver function
- Patients with stage 4 or 5 chronic kidney disease
- Patients with hyperthyroidism and pheochromocytoma
- Patients with seizures requiring medication
- Pregnant women
- Patients with tympanic membrane perforation
- Patients allergic to dexmedetomidine;
- For any reason, it is not possible to cooperate with the study or the researcher considers it inappropriate to be included in this experiment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine 0.5 μg/kg Dexmedetomidine 0.5 μg/kg Participants inhale 0.5 μg/kg dexmedetomidine prepared in 2 ml 0.9% saline. Dexmedetomidine 1 μg/kg Dexmedetomidine 1 μg/kg Participants inhale 1 μg/kg dexmedetomidine prepared in 2 ml 0.9% saline. Placebo Saline Participants inhale 2 ml atomized 0.9% saline.
- Primary Outcome Measures
Name Time Method FVC 10 minutes and 30 minutes after administration of nebulized drugs Forced vital capacity
- Secondary Outcome Measures
Name Time Method PEF 10 minutes and 30 minutes after administration of nebulized drugs Peak expiratory flow
FEV1/FVC% 10 minutes and 30 minutes after administration of nebulized drugs Forced expiratory volume in one second/Forced vital capacity
BEV 10 minutes and 30 minutes after administration of nebulized drugs Back-extrapolation volume
FEV1 10 minutes and 30 minutes after administration of nebulized drugs Forced expiratory volume in one second
FIF25, FIF50, FIF75 10 minutes and 30 minutes after administration of nebulized drugs forced inspiratory flow at 25%, 50%, and 75% of FIVC
MMEF 10 minutes and 30 minutes after administration of nebulized drugs maximal mid-expiratory flow curve
FET 10 minutes and 30 minutes after administration of nebulized drugs Forced expiratory time
heart rate 10 minutes and 30 minutes after administration of nebulized drugs heart rate (beat per min)
FEV1/VC 10 minutes and 30 minutes after administration of nebulized drugs Forced expiratory volume in one second/vital capacity
VC 10 minutes and 30 minutes after administration of nebulized drugs Vital capacity
FEF25%，FEF50%，FEF75%， 10 minutes and 30 minutes after administration of nebulized drugs forced expiratory flow at 25%, 50%, and 75% of FVC exhaled
PIF 10 minutes and 30 minutes after administration of nebulized drugs peak inspiratory flow
FIVC 10 minutes and 30 minutes after administration of nebulized drugs forced inspiratory vital capacity
FIV1 10 minutes and 30 minutes after administration of nebulized drugs forced inspiratory volume in 1 second
MVV 10 minutes and 30 minutes after administration of nebulized drugs maximal ventilatory volume
Richmond Agitation-Sedation Scale (RASS) 10 minutes and 30 minutes after administration of nebulized drugs RASS 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).
Systolic and diastolic blood pressures 10 minutes and 30 minutes after administration of nebulized drugs Systolic and diastolic blood pressures (mmHg)
SPO2 10 minutes and 30 minutes after administration of nebulized drugs Pulse oximetry (SpO2)
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China