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

NCT06207331 | Terminated

• 1 other identifier: 2023.134
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Function Tests; Chronic Obstructive Pulmonary Disease; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• FVC

  Forced vital capacity

  10 minutes and 30 minutes after administration of nebulized drugs

Secondary Outcomes (18)

• FEV1

  10 minutes and 30 minutes after administration of nebulized drugs

• FEV1/FVC%

  10 minutes and 30 minutes after administration of nebulized drugs

• MMEF

  10 minutes and 30 minutes after administration of nebulized drugs

• PEF

  10 minutes and 30 minutes after administration of nebulized drugs

• BEV

  10 minutes and 30 minutes after administration of nebulized drugs

Study Arms (3)

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.

Drug: Saline

Interventions

Dexmedetomidine 0.5 μg/kg DRUG

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

Also known as: Dexmedetomidine Hydrochloride

Dexmedetomidine 1 μg/kg DRUG

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

Also known as: Dexmedetomidine Hydrochloride

Saline DRUG

Participants inhale atomized 2 ml 0.9% saline.

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (11)

• 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.

  PMID: 14739811 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.

  PMID: 17888193 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.

  PMID: 32255904 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.

  PMID: 35510198 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.

  PMID: 34441805 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.

  PMID: 26273134 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.

  PMID: 30103679 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.

  PMID: 32843795 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.

  PMID: 26716866 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.

  PMID: 32547872 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.

  PMID: 36924790 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bing Chen, PhD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 17, 2024
• Study Start: October 28, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 31, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available when we publish and keep it for five years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (1)