Respiratory Function TestsNCT06207331
Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
A study testing Dexmedetomidine 0.5 μg/kg, Dexmedetomidine 1 μg/kg and Saline in people with Respiratory Function Tests and Chronic Obstructive Pulmonary Disease, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Respiratory Function Tests, Chronic Obstructive Pulmonary Disease, Dexmedetomidine
- What is being tested?
- Dexmedetomidine 0.5 μg/kg, Dexmedetomidine 1 μg/kg and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
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.
Read the 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.
- Being tested
- Dexmedetomidine 0.5 μg/kg, Dexmedetomidine 1 μg/kg, Saline
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.5 μg/kgDrug
Also called Dexmedetomidine Hydrochloride
Participants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
Dexmedetomidine 1 μg/kgDrug
Also called Dexmedetomidine Hydrochloride
Participants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline.
SalineDrug
Also called Normal Saline
Participants inhale atomized 2 ml 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC
Forced vital capacity
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
Secondary outcomes (18)
FEV1
Forced expiratory volume in one second
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FEV1/FVC%
Forced expiratory volume in one second/Forced vital capacity
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
MMEF
maximal mid-expiratory flow curve
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
PEF
Peak expiratory flow
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
BEV
Back-extrapolation volume
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FET
Forced expiratory time
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
VC
Vital capacity
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FEV1/VC
Forced expiratory volume in one second/vital capacity
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FEF25%，FEF50%，FEF75%，
forced expiratory flow at 25%, 50%, and 75% of FVC exhaled
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
PIF
peak inspiratory flow
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FIVC
forced inspiratory vital capacity
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FIF25, FIF50, FIF75
forced inspiratory flow at 25%, 50%, and 75% of FIVC
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
FIV1
forced inspiratory volume in 1 second
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
MVV
maximal ventilatory volume
Measured: 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).
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
heart rate
heart rate (beat per min)
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
Systolic and diastolic blood pressures
Systolic and diastolic blood pressures (mmHg)
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
SPO2
Pulse oximetry (SpO2)
Measured: 10 minutes and 30 minutes after administration of nebulized drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start28 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: no patient enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Chen, Ph.D, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Bing Chen, PhD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207331
- Sponsor's protocol ID
- 2023.134
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available with the corresponding author when required.
Publications
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.
PubMed 14739811Yamakage 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.
PubMed 17888193Di 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.
PubMed 32255904Jiang 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.
PubMed 35510198Kostroglou 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.
PubMed 34441805Xia 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.
PubMed 26273134Hasanin 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.
PubMed 30103679Jannu 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.
PubMed 32843795Lee 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.
PubMed 26716866Xu 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.
PubMed 32547872Yang 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.
PubMed 36924790
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06207331
- Acronym / sponsor ID
- 2023.134
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no patient enrolled.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: SalineParticipants inhale 2 ml atomized 0.9% saline. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine 0.5 μg/kgAlso: Dexmedetomidine HydrochlorideParticipants inhale the atomized 0.5 μg/kg dexmedetomidine in 2 ml of 0.9% saline. | Drug | – |
| Dexmedetomidine 1 μg/kgAlso: Dexmedetomidine HydrochlorideParticipants inhale the atomized 1 μg/kg dexmedetomidine in 2 ml of 0.9% saline. | Drug | – |
| SalineAlso: Normal SalineParticipants inhale atomized 2 ml 0.9% saline. | Drug | Placebo |
Primary outcome
FVC
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
Forced vital capacity
18 secondary outcomes
FEV1
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
FEV1/FVC%
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
MMEF
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
PEF
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
BEV
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
FET
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
VC
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
FEV1/VC
Time frame: 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
PIF
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
FIVC
Time frame: 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
FIV1
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
MVV
Time frame: 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
heart rate
Time frame: 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
SPO2
Time frame: 10 minutes and 30 minutes after administration of nebulized drugs
Results and safety
The study was stopped early (reason given: no patient enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 14739811Groeben 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.
- Background: PubMed 17888193Yamakage 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.
- Background: PubMed 32255904Di 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.
- Background: PubMed 35510198Jiang 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.
- Background: PubMed 34441805Kostroglou 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.
- Background: PubMed 26273134Xia 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.
- Background: PubMed 30103679Hasanin 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.
- Background: PubMed 32843795Jannu 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.
- Background: PubMed 26716866Lee 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.
- Background: PubMed 32547872Xu 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.
- Background: PubMed 36924790Yang 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available with the corresponding author when required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing Chen, PhD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine 0.5 μg/kg, Dexmedetomidine 1 μg/kg and Saline in people with Respiratory Function Tests and Chronic Obstructive Pulmonary Disease, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no patient enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (time frame: 10 minutes and 30 minutes after administration of nebulized drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207331, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.