Acute Lung Injury(ALI)NCT07145814
Dexmedetomidine Dose-Dependent on Lung Function and AQP1 in One-Lung Ventilation Surgery
A study testing dexmedetomidine 0.3 µg/kg/h, dexmedetomidine 0.5 µg/kg/h and 0.9 % saline in people with Acute Lung Injury(ALI), run by People's Hospital of Guangxi Zhuang Autonomous Region at 1 site in China.
Trial summary
This randomized controlled trial evaluated the dose-dependent effects of dexmedetomidine (DEX) on pulmonary function and aquaporin-1 (AQP1) expression during one-lung ventilation (OLV) in thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Acute Lung Injury(ALI)
- What is being tested?
- dexmedetomidine 0.3 µg/kg/h, dexmedetomidine 0.5 µg/kg/h and 0.9 % saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2018to 29 Mar 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II
- Age 40-70 years
- Body mass index (BMI) 18-30 kg/m²
Who cannot join
- Preoperative tumor radiotherapy or chemotherapy
- Immune or endocrine disorders
- Hepatic or renal dysfunction
- Preoperative corticosteroid use
- Recent respiratory infection or chronic lung disease
- Sick sinus syndrome or atrioventricular block
- Preoperative anemia (hemoglobin < 90 g/L)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541002
About this study
Official title: Dexmedetomidine Dose-Dependent Modulation of Lung Function and AQP1 Expression During One-Lung Ventilation in Adults Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial
This randomized controlled trial evaluated the dose-dependent effects of dexmedetomidine (DEX) on pulmonary function and aquaporin-1 (AQP1) expression during one-lung ventilation (OLV) in thoracoscopic surgery.
- Conditions
- Acute Lung Injury(ALI)
- Being tested
- dexmedetomidine 0.3 µg/kg/h, dexmedetomidine 0.5 µg/kg/h, 0.9 % saline
- Keywords
- Dexmedetomidine, Aquaporins, Lung Function, One-lung ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine 0.3 µg/kg/hDrug
Following Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation.
dexmedetomidine 0.5 µg/kg/hDrug
Following Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation.
0.9 % salineDrug
Placebo group received an equivalent volume of 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo group received an equivalent volume of 0.9% saline. Receives: Drug: 0.9 % saline |
| dexmedetomidine Low Dose group | Experimental | Following Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation. Receives: Drug: dexmedetomidine 0.3 µg/kg/h |
| dexmedetomidine high dose group | Experimental | Following Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation. Receives: Drug: dexmedetomidine 0.5 µg/kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
aquaporin-1 (AQP1) expression during one-lung ventilation in thoracoscopic surgery
AQP1 expression, serving as an indicator of pulmonary interstitial water permeability, was assessed by immunohistochemistry (IHC) on lung tissue samples. Two histologically normal specimens (1×1×1 cm³ each) were collected per patient: 1) Before one-lung ventilation: ≥ 5 cm from tumor margin in planned resection area; 2) Immediately after lobectomy: ≥ 5 cm from margin in isolated lung. Tissues were fixed in 10% neutral buffered formalin (24 hours), paraffin-embedded, and sectioned (3 μm). Five random high-power fields (HPF, 400x) per section were evaluated. The percentage of positive cells (0: 0-25%; 1: 26-50%; 2: 51-75%; 3: 76-100%) and staining intensity (0: none; 1: light yellow; 2: brown; 3: dark brown) were scored. The total IHC score (range 0-9) was calculated as (percentage score x intensity score); specimens were classified as low (≤ 4) or high (> 4) AQP1 expression.
Measured: before one-lung ventilation, Immediately after lobectomy
Secondary outcomes (2)
Pulmonary function during one-lung ventilation in thoracoscopic surgery, including lung compliance (Cdyn)
Radial arterial blood samples were drawn for blood gas analysis at the specified time points. Dynamic lung compliance (Cdyn) was recorded from the anesthesia machine.
Measured: pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation
Pulmonary function during one-lung ventilation in thoracoscopic surgery, including respiratory index (RI), and oxygenation index (OI).
Radial arterial blood samples were drawn for blood gas analysis at the specified time points. The respiratory index (RI) and oxygenation index (OI) were calculated as:
RI=P(A-aDO2)/PaO2=[(Pb-PH2O) × FiO2-PaO2-PaCO2/RQ]/PaO2. OI= PaO2/FiO2. P(A-aDO2) - alveolar-arterial blood oxygen partial pressure difference, PaCO2 - partial arterial pressure of CO2, Pb - barometric pressure (760 mmHg), pH2O - partial pressure of water vapor (47 mmHg), RQ - respiratory quotient (0.8).
Measured: pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start5 Jan 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung Injury(ALI)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanqiang Li, People's Hospital of Guangxi Zhuang Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145814
- Sponsor's protocol ID
- 2016NXSYYEC-007
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Dose-Dependent Modulation of Lung Function and AQP1 Expression During One-Lung Ventilation in Adults Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07145814
- Acronym / sponsor ID
- 2016NXSYYEC-007
- Conditions
- Acute Lung Injury(ALI)
- Keywords
- Dexmedetomidine, Aquaporins, Lung Function, One-lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous RegionUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 28 Aug 2025 (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.
This randomized controlled trial evaluated the dose-dependent effects of dexmedetomidine (DEX) on pulmonary function and aquaporin-1 (AQP1) expression during one-lung ventilation (OLV) in thoracoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: 0.9 % salinePlacebo group received an equivalent volume of 0.9% saline. |
| dexmedetomidine Low Dose group | Experimental | Drug: dexmedetomidine 0.3 µg/kg/hFollowing Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation. |
| dexmedetomidine high dose group | Experimental | Drug: dexmedetomidine 0.5 µg/kg/hFollowing Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- Age 40-70 years
- Body mass index (BMI) 18-30 kg/m²
Key exclusion criteria (7 listed)
- Preoperative tumor radiotherapy or chemotherapy
- Immune or endocrine disorders
- Hepatic or renal dysfunction
- Preoperative corticosteroid use
- Recent respiratory infection or chronic lung disease
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 0.3 µg/kg/hFollowing Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation. | Drug | dexmedetomidine Low Dose group |
| dexmedetomidine 0.5 µg/kg/hFollowing Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation. | Drug | dexmedetomidine high dose group |
| 0.9 % salinePlacebo group received an equivalent volume of 0.9% saline. | Drug | Placebo group |
Primary outcome
aquaporin-1 (AQP1) expression during one-lung ventilation in thoracoscopic surgery
Time frame: before one-lung ventilation, Immediately after lobectomy
AQP1 expression, serving as an indicator of pulmonary interstitial water permeability, was assessed by immunohistochemistry (IHC) on lung tissue samples. Two histologically normal specimens (1×1×1 cm³ each) were collected per patient: 1) Before one-lung ventilation: ≥ 5 cm from tumor margin in planned resection area; 2) Immediately after lobectomy: ≥ 5 cm from margin in isolated lung. Tissues were fixed in 10% neutral buffered formalin (24 hours), paraffin-embedded, and sectioned (3 μm). Five random high-power fields (HPF, 400x) per section were evaluated. The percentage of positive cells (0: 0-25%; 1: 26-50%; 2: 51-75%; 3: 76-100%) and staining intensity (0: none; 1: light yellow; 2: brown; 3: dark brown) were scored. The total IHC score (range 0-9) was calculated as (percentage score x intensity score); specimens were classified as low (≤ 4) or high (> 4) AQP1 expression.
2 secondary outcomes
Pulmonary function during one-lung ventilation in thoracoscopic surgery, including lung compliance (Cdyn)
Time frame: pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation
Pulmonary function during one-lung ventilation in thoracoscopic surgery, including respiratory index (RI), and oxygenation index (OI).
Time frame: pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 0.3 µg/kg/h, dexmedetomidine 0.5 µg/kg/h and 0.9 % saline in people with Acute Lung Injury(ALI), run by People's Hospital of Guangxi Zhuang Autonomous Region 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 28 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
aquaporin-1 (AQP1) expression during one-lung ventilation in thoracoscopic surgery (time frame: before one-lung ventilation, Immediately after lobectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.