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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207331
• Other study ID #: 2023.134
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: He Huang, PhD
• Phone: 8613708385559
• Email: huanghe[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dexmedetomidine
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Function Tests

Intervention

Drug:
• Dexmedetomidine 0.5 µg/kg
Participants inhale the atomized 0.5 µg/kg dexmedetomidine in 2 ml of 0.9% saline.
• Dexmedetomidine 1 µg/kg
Participants inhale the atomized 1 µg/kg dexmedetomidine in 2 ml of 0.9% saline.
• Saline
Participants inhale atomized 2 ml 0.9% saline.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC	Forced vital capacity	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FEV1	Forced expiratory volume in one second	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FEV1/FVC%	Forced expiratory volume in one second/Forced vital capacity	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	MMEF	maximal mid-expiratory flow curve	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	PEF	Peak expiratory flow	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	BEV	Back-extrapolation volume	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FET	Forced expiratory time	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	VC	Vital capacity	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FEV1/VC	Forced expiratory volume in one second/vital capacity	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FEF25%,FEF50%,FEF75%,	forced expiratory flow at 25%, 50%, and 75% of FVC exhaled	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	PIF	peak inspiratory flow	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FIVC	forced inspiratory vital capacity	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FIF25, FIF50, FIF75	forced inspiratory flow at 25%, 50%, and 75% of FIVC	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	FIV1	forced inspiratory volume in 1 second	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	MVV	maximal ventilatory volume	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	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
Secondary	heart rate	heart rate (beat per min)	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	Systolic and diastolic blood pressures	Systolic and diastolic blood pressures (mmHg)	10 minutes and 30 minutes after administration of nebulized drugs
Secondary	SPO2	Pulse oximetry (SpO2)	10 minutes and 30 minutes after administration of nebulized drugs