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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 0.5 μg/kg | Experimental | Participants inhale 0.5 μg/kg dexmedetomidine prepared in 2 ml 0.9% saline. | |
| Dexmedetomidine 1 μg/kg | Experimental | Participants inhale 1 μg/kg dexmedetomidine prepared in 2 ml 0.9% saline. | |
| Placebo | Placebo Comparator | Participants inhale 2 ml atomized 0.9% saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine 0.5 μg/kg | Drug | Participants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FVC | Forced vital capacity | 10 minutes and 30 minutes after administration of nebulized drugs |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | Forced expiratory volume in one second | 10 minutes and 30 minutes after administration of nebulized drugs |
| FEV1/FVC% | Forced expiratory volume in one second/Forced vital capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bing Chen, PhD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14739811 | Background | Groeben H, Mitzner W, Brown RH. Effects of the alpha2-adrenoceptor agonist dexmedetomidine on bronchoconstriction in dogs. Anesthesiology. 2004 Feb;100(2):359-63. doi: 10.1097/00000542-200402000-00026. | |
| 17888193 | Background | Yamakage M, Iwasaki S, Satoh JI, Namiki A. Inhibitory effects of the alpha-2 adrenergic agonists clonidine and dexmedetomidine on enhanced airway tone in ovalbumin-sensitized guinea pigs. Eur J Anaesthesiol. 2008 Jan;25(1):67-71. doi: 10.1017/S0265021507002591. Epub 2007 Sep 21. |
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Individual participant data (IPD) will be available with the corresponding author when required.
The data will be available when we publish and keep it for five years.
Researchers who provide a methodologically sound proposal.
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| Dexmedetomidine 1 μg/kg | Drug | Participants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline. |
|
| Saline | Drug | Participants inhale atomized 2 ml 0.9% saline. |
|
|
| 10 minutes and 30 minutes after administration of nebulized drugs |
| MMEF | maximal mid-expiratory flow curve | 10 minutes and 30 minutes after administration of nebulized drugs |
| PEF | Peak expiratory flow | 10 minutes and 30 minutes after administration of nebulized drugs |
| BEV | Back-extrapolation volume | 10 minutes and 30 minutes after administration of nebulized drugs |
| FET | Forced expiratory time | 10 minutes and 30 minutes after administration of nebulized drugs |
| VC | Vital capacity | 10 minutes and 30 minutes after administration of nebulized drugs |
| FEV1/VC | Forced expiratory volume in one second/vital capacity | 10 minutes and 30 minutes after administration of nebulized drugs |
| FEF25%,FEF50%,FEF75%, | forced expiratory flow at 25%, 50%, and 75% of FVC exhaled | 10 minutes and 30 minutes after administration of nebulized drugs |
| PIF | peak inspiratory flow | 10 minutes and 30 minutes after administration of nebulized drugs |
| FIVC | forced inspiratory vital capacity | 10 minutes and 30 minutes after administration of nebulized drugs |
| FIF25, FIF50, FIF75 | forced inspiratory flow at 25%, 50%, and 75% of FIVC | 10 minutes and 30 minutes after administration of nebulized drugs |
| FIV1 | forced inspiratory volume in 1 second | 10 minutes and 30 minutes after administration of nebulized drugs |
| MVV | maximal ventilatory volume | 10 minutes and 30 minutes after administration of nebulized drugs |
| Richmond Agitation-Sedation Scale (RASS) | 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). | 10 minutes and 30 minutes after administration of nebulized drugs |
| heart rate | heart rate (beat per min) | 10 minutes and 30 minutes after administration of nebulized drugs |
| Systolic and diastolic blood pressures | Systolic and diastolic blood pressures (mmHg) | 10 minutes and 30 minutes after administration of nebulized drugs |
| SPO2 | Pulse oximetry (SpO2) | 10 minutes and 30 minutes after administration of nebulized drugs |
| 32255904 | Background | Di Bella C, Skouropoulou D, Stabile M, Muresan C, Grasso S, Lacitignola L, Valentini L, Crovace A, Staffieri F. Respiratory and hemodynamic effects of 2 protocols of low-dose infusion of dexmedetomidine in dogs under isoflurane anesthesia. Can J Vet Res. 2020 Apr;84(2):96-107. |
| 35510198 | Background | Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870. |
| 34441805 | Background | Kostroglou A, Kapetanakis EI, Matsota P, Tomos P, Kostopanagiotou K, Tomos I, Siristatidis C, Papapanou M, Sidiropoulou T. Monitored Anesthesia Care with Dexmedetomidine Supplemented by Midazolam/Fentanyl versus Midazolam/Fentanyl Alone in Patients Undergoing Pleuroscopy: Effect on Oxygenation and Respiratory Function. J Clin Med. 2021 Aug 9;10(16):3510. doi: 10.3390/jcm10163510. |
| 26273134 | Background | Xia R, Xu J, Yin H, Wu H, Xia Z, Zhou D, Xia ZY, Zhang L, Li H, Xiao X. Intravenous Infusion of Dexmedetomidine Combined Isoflurane Inhalation Reduces Oxidative Stress and Potentiates Hypoxia Pulmonary Vasoconstriction during One-Lung Ventilation in Patients. Mediators Inflamm. 2015;2015:238041. doi: 10.1155/2015/238041. Epub 2015 Jul 26. |
| 30103679 | Background | Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y. |
| 32843795 | Background | Jannu V, Dhorigol MG. Effect of Intraoperative Dexmedetomidine on Postoperative Pain and Pulmonary Function Following Video-assisted Thoracoscopic Surgery. Anesth Essays Res. 2020 Jan-Mar;14(1):68-71. doi: 10.4103/aer.AER_9_20. Epub 2020 Mar 16. |
| 26716866 | Background | Lee SH, Kim N, Lee CY, Ban MG, Oh YJ. Effects of dexmedetomidine on oxygenation and lung mechanics in patients with moderate chronic obstructive pulmonary disease undergoing lung cancer surgery: A randomised double-blinded trial. Eur J Anaesthesiol. 2016 Apr;33(4):275-82. doi: 10.1097/EJA.0000000000000405. |
| 32547872 | Background | Xu B, Gao H, Li D, Hu C, Yang J. Nebulized dexmedetomidine improves pulmonary shunt and lung mechanics during one-lung ventilation: a randomized clinical controlled trial. PeerJ. 2020 Jun 5;8:e9247. doi: 10.7717/peerj.9247. eCollection 2020. |
| 36924790 | Background | Yang L, Cai Y, Dan L, Huang H, Chen B. Effects of dexmedetomidine on pulmonary function in patients receiving one-lung ventilation: a meta-analysis of randomized controlled trial. Korean J Anesthesiol. 2023 Dec;76(6):586-596. doi: 10.4097/kja.22787. Epub 2023 Mar 16. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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