Clinical Trials Directory

Trials / Terminated

TerminatedNCT06207331

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidine 0.5 μg/kgParticipants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
DRUGDexmedetomidine 1 μg/kgParticipants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
DRUGSalineParticipants inhale atomized 2 ml 0.9% saline.

Timeline

Start date
2023-10-28
Primary completion
2024-06-30
Completion
2024-06-30
First posted
2024-01-17
Last updated
2025-05-31

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06207331. Inclusion in this directory is not an endorsement.