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

May 28, 2025 updated by: Bing Chen, Ph.D, The Second Affiliated Hospital of Chongqing Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • The Second Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dexmedetomidine 0.5 μg/kg
Participants inhale 0.5 μg/kg dexmedetomidine prepared in 2 ml 0.9% saline.
Drug: Dexmedetomidine 0.5 μg/kg
Participants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
Other Names:
  • Dexmedetomidine Hydrochloride
Experimental: Dexmedetomidine 1 μg/kg
Participants inhale 1 μg/kg dexmedetomidine prepared in 2 ml 0.9% saline.
Drug: Dexmedetomidine 1 μg/kg
Participants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
Other Names:
  • Dexmedetomidine Hydrochloride
Placebo Comparator: Placebo
Participants inhale 2 ml atomized 0.9% saline.
Drug: Saline
Participants inhale atomized 2 ml 0.9% saline.
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FVC
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Forced vital capacity
10 minutes and 30 minutes after administration of nebulized drugs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FEV1
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Forced expiratory volume in one second
10 minutes and 30 minutes after administration of nebulized drugs
FEV1/FVC%
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Forced expiratory volume in one second/Forced vital capacity
10 minutes and 30 minutes after administration of nebulized drugs
MMEF
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
maximal mid-expiratory flow curve
10 minutes and 30 minutes after administration of nebulized drugs
PEF
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Peak expiratory flow
10 minutes and 30 minutes after administration of nebulized drugs
BEV
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Back-extrapolation volume
10 minutes and 30 minutes after administration of nebulized drugs
FET
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Forced expiratory time
10 minutes and 30 minutes after administration of nebulized drugs
VC
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Vital capacity
10 minutes and 30 minutes after administration of nebulized drugs
FEV1/VC
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Forced expiratory volume in one second/vital capacity
10 minutes and 30 minutes after administration of nebulized drugs
FEF25%，FEF50%，FEF75%，
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
forced expiratory flow at 25%, 50%, and 75% of FVC exhaled
10 minutes and 30 minutes after administration of nebulized drugs
PIF
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
peak inspiratory flow
10 minutes and 30 minutes after administration of nebulized drugs
FIVC
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
forced inspiratory vital capacity
10 minutes and 30 minutes after administration of nebulized drugs
FIF25, FIF50, FIF75
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
forced inspiratory flow at 25%, 50%, and 75% of FIVC
10 minutes and 30 minutes after administration of nebulized drugs
FIV1
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
forced inspiratory volume in 1 second
10 minutes and 30 minutes after administration of nebulized drugs
MVV
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
maximal ventilatory volume
10 minutes and 30 minutes after administration of nebulized drugs
Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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).
10 minutes and 30 minutes after administration of nebulized drugs
heart rate
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
heart rate (beat per min)
10 minutes and 30 minutes after administration of nebulized drugs
Systolic and diastolic blood pressures
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Systolic and diastolic blood pressures (mmHg)
10 minutes and 30 minutes after administration of nebulized drugs
SPO2
Time Frame: 10 minutes and 30 minutes after administration of nebulized drugs
Pulse oximetry (SpO2)
10 minutes and 30 minutes after administration of nebulized drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Second Affiliated Hospital of Chongqing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bing Chen, PhD, The Second Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be available with the corresponding author when required.

IPD Sharing Time Frame

The data will be available when we publish and keep it for five years.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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