- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325773
Effects of Magnesium Sulfate on Oxygenation and Lung Mechanics During One-Lung Ventilation
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: İlayda AKARSU KAYA, Anesthesiology Resident, Principal Investigator
- Phone Number: +905073306901
- Email: ilaydaakarsu96@gmail.com
Study Contact Backup
- Name: Meliha ORHON ERGÜN
- Phone Number: +905413402001
- Email: dr.meliha@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34854
- Recruiting
- Marmara University Faculty of Medicine, Basibuyuk Campus
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Contact:
- İlayda AKARSU KAYA, Anesthesiology Resident, Principal Investigator
- Phone Number: +905073306901
- Email: ilaydaakarsu96@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group 1 - Magnesium Sulfate Group Label: Magnesium Sulfate Group
Patients receiving intravenous magnesium sulfate during the surgery as part of standard anesthetic management.
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Group 2 - Control Group Label: Control Group
Patients undergoing one-lung ventilation without the administration of magnesium sulfate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
Time Frame: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours)
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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.
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From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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.
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From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours).
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Dynamic Lung Compliance and Airway Resistance (Raw)
Time Frame: Intraoperative period (approximately 2-3 hours).
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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.
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Intraoperative period (approximately 2-3 hours).
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Postoperative Arterial Oxygen Partial Pressure (PaO₂) on Room Air
Time Frame: Within the first postoperative hour while breathing room air.
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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.
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Within the first postoperative hour while breathing room air.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Meliha ORHON ERGÜN, Marmara University Faculty of Medicine, Department of Anesthesiology and Reanimation
- Principal Investigator: İlayda AKARSU KAYA, Marmara University Faculty of Medicine, Department of Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09.2025.463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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