Intraoperative Oxygenation and Pulmonary MechanicsNCT07325773
Effects of Magnesium Sulfate on Oxygenation and Lung Mechanics During One-Lung Ventilation
An observational study of Intraoperative Oxygenation and Pulmonary Mechanics, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effects of intravenous magnesium sulfate on intraoperative oxygenation and lung mechanics in patients undergoing thoracic surgery with one-lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intraoperative Oxygenation and Pulmonary Mechanics
- Type of treatment
- Injection or infusion
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 28 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients undergoing elective thoracic surgery performed with video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation under general anesthesia. The study population consists of individuals scheduled for minimally invasive lung resections or other VATS procedures necessitating lung isolation. Patients receiving magnesium sulfate intraoperatively and those not receiving it will be prospectively observed. Patients undergoing pneumonectomy, those with significant organ failure, extreme BMI values, or inadequate pulmonary function will be excluded.
Who may be able to join
- Adults aged 18 to 80 years Scheduled for elective thoracic surgery performed with video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation under general anesthesia.
- ASA physical status II-III Ability to provide informed consent Undergoing general anesthesia with double-lumen tube placement
Who cannot join
- Patients undergoing pneumonectomy
- Patients with renal, hepatic, or cardiovascular failure
- Patients with a BMI < 15 kg/m² or > 35 kg/m²
- Patients with a preoperative pulmonary function test showing FEV₁ < 1.5 liters
- Patients who are transferred to the intensive care unit intubated in the postoperative period
- Patients with physical or mental conditions that prevent the performance of pulmonary function testing factors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
İlayda AKARSU KAYA, Anesthesiology Resident, Principal Investigator contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Faculty of Medicine, Basibuyuk Campus
Istanbul, 34854
İlayda AKARSU KAYA, Anesthesiology Resident, Principal Investigator, +905073306901, ilaydaakarsu96@gmail.com
About this study
Official title: Effects of Magnesium Sulfate on Intraoperative Oxygenation and Lung Mechanics During One-Lung Ventilation: A Prospective Observational Study
This prospective observational study aims to evaluate the effects of intravenous magnesium sulfate on intraoperative oxygenation and lung mechanics in patients undergoing thoracic surgery with one-lung ventilation. Magnesium sulfate has been reported to have potential bronchodilatory and anti-inflammatory properties, which may improve gas exchange and respiratory mechanics during lung isolation.
In this study, patients who receive magnesium sulfate as part of standard anesthetic management will be compared with those who do not receive the drug. Oxygenation parameters, dynamic and static lung mechanics, airway pressures, and ventilation-related indices will be recorded throughout the intraoperative period. The findings of this study may help clarify whether magnesium sulfate provides measurable respiratory benefits during one-lung ventilation.
- Keywords
- Magnesium Sulfate, One-Lung Ventilation, Lung Mechanics, Oxygenation, Airway Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Magnesium Sulfate Group Label: Magnesium Sulfate Group | Patients receiving intravenous magnesium sulfate during the surgery as part of standard anesthetic management. | |
| Group 2 - Control Group Label: Control Group | Patients undergoing one-lung ventilation without the administration of magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
The PaO₂/FiO₂ ratio will be measured to evaluate intraoperative oxygenation during the surgery. Measurements will be recorded after induction of anesthesia (baseline) and at predefined intraoperative time points. The primary outcome is the change in PaO₂/FiO₂ ratio between baseline and intraoperative measurements in patients receiving magnesium sulfate versus control.
Measured: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours)
Secondary outcomes (3)
Changes in Airway Pressures (Peak and Plateau Pressures)
Peak inspiratory pressure (PIP) and plateau pressure (Pplat) will be measured to assess changes in airway pressures during one-lung ventilation in patients receiving magnesium sulfate compared with control.
Measured: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours).
Dynamic Lung Compliance and Airway Resistance (Raw)
Dynamic compliance (Cdyn) will be recorded at predefined intraoperative time points to evaluate changes in pulmonary mechanics associated with magnesium sulfate administration.Airway resistance (Raw) will be measured at predefined intraoperative time points using ventilator-derived data. Raw will be compared between patients receiving magnesium sulfate and those in the control group to assess the effect of magnesium sulfate on airway resistance during one-lung ventilation.
Measured: Intraoperative period (approximately 2-3 hours).
Postoperative Arterial Oxygen Partial Pressure (PaO₂) on Room Air
Arterial oxygen partial pressure (PaO₂) will be measured in the postoperative period while patients are breathing room air. This outcome will be used to assess whether intraoperative magnesium sulfate administration has an effect on early postoperative oxygenation following one-lung ventilation.
Measured: Within the first postoperative hour while breathing room air.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Dec 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Oxygenation and Pulmonary MechanicsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
- Investigators
- Meliha ORHON ERGÜN, Study chair, Marmara University Faculty of Medicine, Department of Anesthesiology and Reanimationİlayda AKARSU KAYA, Principal investigator, Marmara University Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325773
- Sponsor's protocol ID
- 09.2025.463
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Sulfate on Intraoperative Oxygenation and Lung Mechanics During One-Lung Ventilation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07325773
- Acronym / sponsor ID
- 09.2025.463
- Keywords
- Magnesium Sulfate, One-Lung Ventilation, Lung Mechanics, Oxygenation, Airway Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 8 Jan 2026 (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 prospective observational study aims to evaluate the effects of intravenous magnesium sulfate on intraoperative oxygenation and lung mechanics in patients undergoing thoracic surgery with one-lung ventilation. Magnesium sulfate has been reported to have potential bronchodilatory and anti-inflammatory properties, which may improve gas exchange and respiratory mechanics during lung isolation.
In this study, patients who receive magnesium sulfate as part of standard anesthetic management will be compared with those who do not receive the drug. Oxygenation parameters, dynamic and static lung mechanics, airway pressures, and ventilation-related indices will be recorded throughout the intraoperative period. The findings of this study may help clarify whether magnesium sulfate provides measurable respiratory benefits during one-lung ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Magnesium Sulfate Group Label: Magnesium Sulfate Group | – | –Patients receiving intravenous magnesium sulfate during the surgery as part of standard anesthetic management. |
| Group 2 - Control Group Label: Control Group | – | –Patients undergoing one-lung ventilation without the administration of magnesium sulfate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients undergoing elective thoracic surgery performed with video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation under general anesthesia. The study population consists of individuals scheduled for minimally invasive lung resections or other VATS procedures necessitating lung isolation. Patients receiving magnesium sulfate intraoperatively and those not receiving it will be prospectively observed. Patients undergoing pneumonectomy, those with significant organ failure, extreme BMI values, or inadequate pulmonary function will be excluded.
Key inclusion criteria (2 listed)
- Adults aged 18 to 80 years Scheduled for elective thoracic surgery performed with video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation under general anesthesia.
- ASA physical status II-III Ability to provide informed consent Undergoing general anesthesia with double-lumen tube placement
Key exclusion criteria (6 listed)
- Patients undergoing pneumonectomy
- Patients with renal, hepatic, or cardiovascular failure
- Patients with a BMI < 15 kg/m² or > 35 kg/m²
- Patients with a preoperative pulmonary function test showing FEV₁ < 1.5 liters
- Patients who are transferred to the intensive care unit intubated in the postoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
Time frame: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours)
The PaO₂/FiO₂ ratio will be measured to evaluate intraoperative oxygenation during the surgery. Measurements will be recorded after induction of anesthesia (baseline) and at predefined intraoperative time points. The primary outcome is the change in PaO₂/FiO₂ ratio between baseline and intraoperative measurements in patients receiving magnesium sulfate versus control.
3 secondary outcomes
Changes in Airway Pressures (Peak and Plateau Pressures)
Time frame: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours).
Dynamic Lung Compliance and Airway Resistance (Raw)
Time frame: Intraoperative period (approximately 2-3 hours).
Postoperative Arterial Oxygen Partial Pressure (PaO₂) on Room Air
Time frame: Within the first postoperative hour while breathing room air.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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.
İlayda AKARSU KAYA, Anesthesiology Resident, Principal Investigator contact
Meliha ORHON ERGÜN study chair
Marmara University Faculty of Medicine, Department of Anesthesiology and Reanimation
İlayda AKARSU KAYA principal investigator
Marmara University Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Oxygenation and Pulmonary Mechanics, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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 Turkey (Türkiye). 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlayda AKARSU KAYA, Anesthesiology Resident, Principal Investigator (+905073306901, ilaydaakarsu96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraoperative Oxygenation (PaO₂/FiO₂ Ratio) (time frame: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours)). 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 8 Jan 2026.