VATSNCT07271472
Oxidative Stress Effects of TIVA, CIVA, and Balanced Anesthesia in VATS
A study testing Total Intravenous Anesthesia (TIVA) Group, Balanced Anesthesia (BAL) Group and Combined Intravenous Volatile Anesthesia in people with VATS and Video Assisted Thoracoscopic Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of our study is to compare the effects of total intravenous anesthesia (TIVA), combined intravenous-volatile anesthesia (CIVA), and balanced anesthesia (BAL) methods on perioperative oxidative stress parameters, such as Malondialdehyde (MDA), Total Oxidant Status (TOS), Total Antioxidant Status… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- VATS, Video Assisted Thoracoscopic Surgery
- What is being tested?
- Total Intravenous Anesthesia (TIVA) Group, Balanced Anesthesia (BAL) Group and Combined Intravenous Volatile Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 2 May 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years,
- American Society of Anesthesiologists (ASA) Physical Status Class I-II,
- Scheduled for elective Video-Assisted Thoracoscopic Surgery (VATS)
- Requiring one-lung ventilation for more than 60 minutes
Who cannot join
- Refusal to participate in the study
- History of allergy to the drugs to be used
- Recent history of vitamin supplementation
- History of severe cardiac, renal, or hepatic disease
- ASA III-IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Intravenous Anesthesia (TIVA), Combined Intravenous-Volatile Anesthesia (CIVA), and Balanced Anesthesia (BAL) on Perioperative Oxidative Stress in Video-Assisted Thoracoscopic Surgery (VATS)
The primary objective of our study is to compare the effects of total intravenous anesthesia (TIVA), combined intravenous-volatile anesthesia (CIVA), and balanced anesthesia (BAL) methods on perioperative oxidative stress parameters, such as Malondialdehyde (MDA), Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Superoxide Dismutase (SOD), in patients undergoing video-assisted thoracoscopic surgery (VATS). The secondary objective is to record perioperative vital parameters, arterial blood gas values obtained at specific stages of the surgery, and the incidence of postoperative nausea and vomiting (PONV).
Read the detailed description
Scientific Rationale and Validity of the Medical Research Hypoxic pulmonary vasoconstriction (HPV) is a homeostatic mechanism unique to the pulmonary vascular system. In response to alveolar hypoxia, intrapulmonary arteries constrict and redirect blood flow toward better-oxygenated lung segments, thereby optimizing ventilation/perfusion matching and systemic oxygenation . Additionally, HPV acts as a physiological protective mechanism by reducing the shunt of deoxygenated blood and improving the degree of hypoxemia. This physiological modulation is influenced by various factors including medications, temperature, acid-base status, airway pressure, patient positioning, and cardiac output . Numerous animal and isolated lung studies have demonstrated that HPV is modulated by volatile anesthetics . However, human studies have reported inconsistent results regarding the effects of various anesthetics on systemic oxygenation during one-lung ventilation.
One-lung ventilation is frequently employed during thoracic surgical procedures such as thoracotomy and thoracoscopy to provide an adequate surgical view. Patients undergoing one-lung ventilation are at risk of hypoxemia due to impaired oxygenation, as well as postoperative lung injury attributable to oxidative damage occurring during reventilation of the non-dependent lung.
During one-lung ventilation, the non-ventilated lung becomes not only atelectatic but also hypoperfused as a result of HPV. Once two-lung ventilation is re-established, the reintroduction of oxygen into the airways triggers reactive pulmonary vasodilation and reperfusion of the lung tissue, which may result in the generation of excessive oxidative radicals. Although the lung is relatively resistant to hypoxia owing to dual blood supply and consumption of oxygen stored in alveolar spaces, re-expansion injury observed after pneumothorax treatment and reperfusion injury following lung transplantation serve as examples of potential oxidative damage .
Research Questions How do TIVA, CIVA, and BAL anesthetic techniques affect oxidative stress responses in patients undergoing one-lung ventilation? Which anesthetic management approach (CIVA, TIVA, BAL) provides better preservation of oxygenation? Will there be a significant difference in postoperative nausea and vomiting (PONV) incidence among the groups? Study Design, Methods, and Procedures Participants Written informed consent will be obtained from all participants. Sixty patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) Physical Status I-II, scheduled for elective video-assisted thoracoscopic surgery (VATS) at Atatürk University Medical Faculty Hospital between December 1, 2025 and May 1, 2026, and requiring one-lung ventilation for more than 60 minutes will be included. Patients will be informed about the study prior to enrollment. Individuals who decline participation, have known allergies to the study drugs, have a recent history of vitamin supplementation, or who have significant cardiovascular, renal, or hepatic disease will be excluded. The study will be conducted in three groups.
Randomization Patients will be randomly assigned into three equal groups (TIVA, CIVA, and BAL) using the Microsoft Excel RAND function. All other investigators and outcome assessors will remain blinded to group allocation.
Total Intravenous Anesthesia (TIVA) Group Anesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60.
Balanced Anesthesia (BAL) Group Induction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60.
Combined Intravenous-Volatile Anesthesia (CIVA) Group Induction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60.
Perioperative Monitoring and Sample Collection Upon arrival to the operating room, standard monitoring (ECG and SpO₂) will be applied. A 20G radial arterial catheter will be inserted under sterile conditions for continuous invasive blood pressure monitoring and blood sampling.
Following induction, patients will be intubated using an appropriately sized (35Fr, 37Fr, or 39Fr) Robertshaw double-lumen endotracheal tube. Position verification will be conducted with a fiberoptic bronchoscope before and after lateral positioning. Pressure-controlled volume-guaranteed (PCV-VG) ventilation will be used during both two-lung and one-lung ventilation with PEEP set at 5 cmH₂O. During one-lung ventilation, tidal volume will be set at 4-6 mL/kg keeping peak inspiratory pressure <30 cmH₂O, FiO₂ between 0.6-1.0 to maintain SpO₂ >90%, and respiratory rate adjusted to ensure normocapnia.
Blood samples for measurement of oxidative stress markers-Malondialdehyde (MDA), Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Superoxide Dismutase (SOD)-will be drawn from the arterial catheter at three time points:
T1: Before anesthesia induction T2: Before re-establishing two-lung ventilation T3: 30 minutes after re-establishing two-lung ventilation Samples will be centrifuged at +4°C, 4500 rpm for 7 minutes. The obtained serum will be stored at -80°C in Eppendorf tubes until analysis. Serum levels will be determined using the ELISA method. Recorded values will be transferred to Excel spreadsheets for evaluation and statistical processing.
During anesthesia, at 15, 30, 45, and 60 minutes of one-lung ventilation and 30 minutes after resuming two-lung ventilation, TCI remifentanil dose, TCI propofol dose, minimum alveolar concentration (MAC), peak inspiratory pressure (Ppeak), BIS values, heart rate, and mean arterial pressure will be recorded. Arterial blood gas samples will be routinely obtained. After extubation, patients will be transferred to the post-anesthesia care unit (PACU) and evaluated for postoperative nausea and vomiting (PONV) at the 30th minute.
Statistical Analysis Statistical analyses will be performed using SPSS Statistics Version 22 (IBM, Armonk, NY, USA). Normality will be assessed with the Kolmogorov-Smirnov test. Normally distributed variables will be analyzed using the Student's t-test, whereas non-normally distributed variables will be evaluated using the Mann-Whitney U test. A p-value < 0.05 will be considered statistically significant.
- Conditions
- VATS, Video Assisted Thoracoscopic Surgery
- Being tested
- Total Intravenous Anesthesia (TIVA) Group, Balanced Anesthesia (BAL) Group, Combined Intravenous Volatile Anesthesia
- Keywords
- Video-Assisted Thoracoscopic Surgery, Total Intravenous Anesthesia, Combined Intravenous Volatile Anesthesia, Balanced Anesthesia, Malondialdehyde, Total Oxidant Status, Total Antioxidant Status, Superoxide Dismutase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Intravenous Anesthesia (TIVA) GroupDrug
Also called TIVA Group
Anesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60.
Balanced Anesthesia (BAL) GroupDrug
Also called BAL Group
Induction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60.
Combined Intravenous Volatile AnesthesiaDrug
Also called CIVA Group
Induction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60.
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) Group | Experimental | Anesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60. Receives: Drug: Total Intravenous Anesthesia (TIVA) Group |
| Balanced Anesthesia (BAL) Group | Experimental | Induction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60. Receives: Drug: Balanced Anesthesia (BAL) Group |
| Combined Intravenous Volatile Anesthesia (CIVA) Group | Experimental | Induction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60. Receives: Drug: Combined Intravenous Volatile Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde levels in perioperatively collected blood samples
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of MDA will be measured using the ELISA method.
Measured: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
Total Antioxidant Status levels in perioperatively collected blood samples
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of TAS will be measured using the ELISA method.
Measured: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
Total Oxidant Status levels in perioperatively collected blood samples
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of TOS will be measured using the ELISA method.
Measured: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
Superoxide Dismutase levels in perioperatively collected blood samples
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of SOD will be measured using the ELISA method.
Measured: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
Secondary outcomes (3)
Postoperative nausea and vomiting
Incidence of post operative nausea and vomiting (PONV)
Measured: From 1 to 24 hour post operatively
Partial pressure of oxygen (PaO₂) values
Arterial blood gas samples will be obtained during anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation, and the partial pressure of oxygen (PaO₂) values will be recorded.
Measured: During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation
Partial pressure of carbon dioxide pressure (PaCO₂)
Arterial blood gas samples will be obtained during anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation, and partial carbon dioxide pressure (PaCO₂) values will be recorded.
Measured: During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to 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 posted9 Dec 2025
- Study start1 Dec 2025
- Primary completion1 May 2026
- Study completion2 May 2026
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 VATSStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Oral Ahiskalioglu, Ataturk University
- Investigators
- Elif Oral Ahiskalioglu, Professor, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271472
- Sponsor's protocol ID
- ATAUNIVATS
- Status last verified
- May 2026
- First submitted
- 25 Nov 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional regulations. Data will be securely stored and used solely for the purposes of this study and related scientific publications.
Publications
Comhair SA, Erzurum SC. Antioxidant responses to oxidant-mediated lung diseases. Am J Physiol Lung Cell Mol Physiol. 2002 Aug;283(2):L246-55. doi: 10.1152/ajplung.00491.2001.
PubMed 12114185Lang JD, McArdle PJ, O'Reilly PJ, Matalon S. Oxidant-antioxidant balance in acute lung injury. Chest. 2002 Dec;122(6 Suppl):314S-320S. doi: 10.1378/chest.122.6_suppl.314s.
PubMed 12475808Cheng YJ, Chan KC, Chien CT, Sun WZ, Lin CJ. Oxidative stress during 1-lung ventilation. J Thorac Cardiovasc Surg. 2006 Sep;132(3):513-8. doi: 10.1016/j.jtcvs.2006.03.060.
PubMed 16935103Sharifian Attar A, Tabari M, Rahnamazadeh M, Salehi M. A comparison of effects of propofol and isoflurane on arterial oxygenation pressure, mean arterial pressure and heart rate variations following one-lung ventilation in thoracic surgeries. Iran Red Crescent Med J. 2014 Feb;16(2):e15809. doi: 10.5812/ircmj.15809. Epub 2014 Feb 8.
PubMed 24719749Xu WY, Wang N, Xu HT, Yuan HB, Sun HJ, Dun CL, Zhou SQ, Zou Z, Shi XY. Effects of sevoflurane and propofol on right ventricular function and pulmonary circulation in patients undergone esophagectomy. Int J Clin Exp Pathol. 2013 Dec 15;7(1):272-9. eCollection 2014.
PubMed 24427348Schwarzkopf K, Schreiber T, Preussler NP, Gaser E, Huter L, Bauer R, Schubert H, Karzai W. Lung perfusion, shunt fraction, and oxygenation during one-lung ventilation in pigs: the effects of desflurane, isoflurane, and propofol. J Cardiothorac Vasc Anesth. 2003 Feb;17(1):73-5. doi: 10.1053/jcan.2003.13.
PubMed 12635064Loer SA, Scheeren TW, Tarnow J. Desflurane inhibits hypoxic pulmonary vasoconstriction in isolated rabbit lungs. Anesthesiology. 1995 Sep;83(3):552-6. doi: 10.1097/00000542-199509000-00014.
PubMed 7661356Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x.
PubMed 9689269Eisenkraft JB. Effects of anaesthetics on the pulmonary circulation. Br J Anaesth. 1990 Jul;65(1):63-78. doi: 10.1093/bja/65.1.63. No abstract available.
PubMed 2200486Lumb AB, Slinger P. Hypoxic pulmonary vasoconstriction: physiology and anesthetic implications. Anesthesiology. 2015 Apr;122(4):932-46. doi: 10.1097/ALN.0000000000000569.
PubMed 25587641Dunham-Snary KJ, Wu D, Sykes EA, Thakrar A, Parlow LRG, Mewburn JD, Parlow JL, Archer SL. Hypoxic Pulmonary Vasoconstriction: From Molecular Mechanisms to Medicine. Chest. 2017 Jan;151(1):181-192. doi: 10.1016/j.chest.2016.09.001. Epub 2016 Sep 16.
PubMed 27645688
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia (TIVA), Combined Intravenous-Volatile Anesthesia (CIVA), and Balanced Anesthesia (BAL) on Perioperative Oxidative Stress in Video-Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT07271472
- Acronym / sponsor ID
- ATAUNIVATS
- Conditions
- VATS, Video Assisted Thoracoscopic Surgery
- Keywords
- Video-Assisted Thoracoscopic Surgery, Total Intravenous Anesthesia, Combined Intravenous Volatile Anesthesia, Balanced Anesthesia, Malondialdehyde, Total Oxidant Status, Total Antioxidant Status, Superoxide Dismutase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 9 Dec 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.
The primary objective of our study is to compare the effects of total intravenous anesthesia (TIVA), combined intravenous-volatile anesthesia (CIVA), and balanced anesthesia (BAL) methods on perioperative oxidative stress parameters, such as Malondialdehyde (MDA), Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Superoxide Dismutase (SOD), in patients undergoing video-assisted thoracoscopic surgery (VATS). The secondary objective is to record perioperative vital parameters, arterial blood gas values obtained at specific stages of the surgery, and the incidence of postoperative nausea and vomiting (PONV).
Detailed description
Scientific Rationale and Validity of the Medical Research Hypoxic pulmonary vasoconstriction (HPV) is a homeostatic mechanism unique to the pulmonary vascular system. In response to alveolar hypoxia, intrapulmonary arteries constrict and redirect blood flow toward better-oxygenated lung segments, thereby optimizing ventilation/perfusion matching and systemic oxygenation . Additionally, HPV acts as a physiological protective mechanism by reducing the shunt of deoxygenated blood and improving the degree of hypoxemia. This physiological modulation is influenced by various factors including medications, temperature, acid-base status, airway pressure, patient positioning, and cardiac output . Numerous animal and isolated lung studies have demonstrated that HPV is modulated by volatile anesthetics . However, human studies have reported inconsistent results regarding the effects of various anesthetics on systemic oxygenation during one-lung ventilation.
One-lung ventilation is frequently employed during thoracic surgical procedures such as thoracotomy and thoracoscopy to provide an adequate surgical view. Patients undergoing one-lung ventilation are at risk of hypoxemia due to impaired oxygenation, as well as postoperative lung injury attributable to oxidative damage occurring during reventilation of the non-dependent lung.
During one-lung ventilation, the non-ventilated lung becomes not only atelectatic but also hypoperfused as a result of HPV. Once two-lung ventilation is re-established, the reintroduction of oxygen into the airways triggers reactive pulmonary vasodilation and reperfusion of the lung tissue, which may result in the generation of excessive oxidative radicals. Although the lung is relatively resistant to hypoxia owing to dual blood supply and consumption of oxygen stored in alveolar spaces, re-expansion injury observed after pneumothorax treatment and reperfusion injury following lung transplantation serve as examples of potential oxidative damage .
Research Questions How do TIVA, CIVA, and BAL anesthetic techniques affect oxidative stress responses in patients undergoing one-lung ventilation? Which anesthetic management approach (CIVA, TIVA, BAL) provides better preservation of oxygenation? Will there be a significant difference in postoperative nausea and vomiting (PONV) incidence among the groups? Study Design, Methods, and Procedures Participants Written informed consent will be obtained from all participants. Sixty patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) Physical Status I-II, scheduled for elective video-assisted thoracoscopic surgery (VATS) at Atatürk University Medical Faculty Hospital between December 1, 2025 and May 1, 2026, and requiring one-lung ventilation for more than 60 minutes will be included. Patients will be informed about the study prior to enrollment. Individuals who decline participation, have known allergies to the study drugs, have a recent history of vitamin supplementation, or who have significant cardiovascular, renal, or hepatic disease will be excluded. The study will be conducted in three groups.
Randomization Patients will be randomly assigned into three equal groups (TIVA, CIVA, and BAL) using the Microsoft Excel RAND function. All other investigators and outcome assessors will remain blinded to group allocation.
Total Intravenous Anesthesia (TIVA) Group Anesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60.
Balanced Anesthesia (BAL) Group Induction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60.
Combined Intravenous-Volatile Anesthesia (CIVA) Group Induction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60.
Perioperative Monitoring and Sample Collection Upon arrival to the operating room, standard monitoring (ECG and SpO₂) will be applied. A 20G radial arterial catheter will be inserted under sterile conditions for continuous invasive blood pressure monitoring and blood sampling.
Following induction, patients will be intubated using an appropriately sized (35Fr, 37Fr, or 39Fr) Robertshaw double-lumen endotracheal tube. Position verification will be conducted with a fiberoptic bronchoscope before and after lateral positioning. Pressure-controlled volume-guaranteed (PCV-VG) ventilation will be used during both two-lung and one-lung ventilation with PEEP set at 5 cmH₂O. During one-lung ventilation, tidal volume will be set at 4-6 mL/kg keeping peak inspiratory pressure <30 cmH₂O, FiO₂ between 0.6-1.0 to maintain SpO₂ >90%, and respiratory rate adjusted to ensure normocapnia.
Blood samples for measurement of oxidative stress markers-Malondialdehyde (MDA), Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Superoxide Dismutase (SOD)-will be drawn from the arterial catheter at three time points:
T1: Before anesthesia induction T2: Before re-establishing two-lung ventilation T3: 30 minutes after re-establishing two-lung ventilation Samples will be centrifuged at +4°C, 4500 rpm for 7 minutes. The obtained serum will be stored at -80°C in Eppendorf tubes until analysis. Serum levels will be determined using the ELISA method. Recorded values will be transferred to Excel spreadsheets for evaluation and statistical processing.
During anesthesia, at 15, 30, 45, and 60 minutes of one-lung ventilation and 30 minutes after resuming two-lung ventilation, TCI remifentanil dose, TCI propofol dose, minimum alveolar concentration (MAC), peak inspiratory pressure (Ppeak), BIS values, heart rate, and mean arterial pressure will be recorded. Arterial blood gas samples will be routinely obtained. After extubation, patients will be transferred to the post-anesthesia care unit (PACU) and evaluated for postoperative nausea and vomiting (PONV) at the 30th minute.
Statistical Analysis Statistical analyses will be performed using SPSS Statistics Version 22 (IBM, Armonk, NY, USA). Normality will be assessed with the Kolmogorov-Smirnov test. Normally distributed variables will be analyzed using the Student's t-test, whereas non-normally distributed variables will be evaluated using the Mann-Whitney U test. A p-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) Group | Experimental | Drug: Total Intravenous Anesthesia (TIVA) GroupAnesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60. |
| Balanced Anesthesia (BAL) Group | Experimental | Drug: Balanced Anesthesia (BAL) GroupInduction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60. |
| Combined Intravenous Volatile Anesthesia (CIVA) Group | Experimental | Drug: Combined Intravenous Volatile AnesthesiaInduction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65 years,
- American Society of Anesthesiologists (ASA) Physical Status Class I-II,
- Scheduled for elective Video-Assisted Thoracoscopic Surgery (VATS)
- Requiring one-lung ventilation for more than 60 minutes
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- History of allergy to the drugs to be used
- Recent history of vitamin supplementation
- History of severe cardiac, renal, or hepatic disease
- ASA III-IV
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 |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) GroupAlso: TIVA GroupAnesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60. | Drug | Total Intravenous Anesthesia (TIVA) Group |
| Balanced Anesthesia (BAL) GroupAlso: BAL GroupInduction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60. | Drug | Balanced Anesthesia (BAL) Group |
| Combined Intravenous Volatile AnesthesiaAlso: CIVA GroupInduction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60. | Drug | Combined Intravenous Volatile Anesthesia (CIVA) Group |
Primary outcome
Malondialdehyde levels in perioperatively collected blood samples
Time frame: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of MDA will be measured using the ELISA method.
Total Antioxidant Status levels in perioperatively collected blood samples
Time frame: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of TAS will be measured using the ELISA method.
Total Oxidant Status levels in perioperatively collected blood samples
Time frame: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of TOS will be measured using the ELISA method.
Superoxide Dismutase levels in perioperatively collected blood samples
Time frame: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation
For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of SOD will be measured using the ELISA method.
3 secondary outcomes
Postoperative nausea and vomiting
Time frame: From 1 to 24 hour post operatively
Partial pressure of oxygen (PaO₂) values
Time frame: During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation
Partial pressure of carbon dioxide pressure (PaCO₂)
Time frame: During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to 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 14 May 2026.
- Results publication: PubMed 12114185Comhair SA, Erzurum SC. Antioxidant responses to oxidant-mediated lung diseases. Am J Physiol Lung Cell Mol Physiol. 2002 Aug;283(2):L246-55. doi: 10.1152/ajplung.00491.2001.
- Results publication: PubMed 12475808Lang JD, McArdle PJ, O'Reilly PJ, Matalon S. Oxidant-antioxidant balance in acute lung injury. Chest. 2002 Dec;122(6 Suppl):314S-320S. doi: 10.1378/chest.122.6_suppl.314s.
- Results publication: PubMed 16935103Cheng YJ, Chan KC, Chien CT, Sun WZ, Lin CJ. Oxidative stress during 1-lung ventilation. J Thorac Cardiovasc Surg. 2006 Sep;132(3):513-8. doi: 10.1016/j.jtcvs.2006.03.060.
- Results publication: PubMed 24719749Sharifian Attar A, Tabari M, Rahnamazadeh M, Salehi M. A comparison of effects of propofol and isoflurane on arterial oxygenation pressure, mean arterial pressure and heart rate variations following one-lung ventilation in thoracic surgeries. Iran Red Crescent Med J. 2014 Feb;16(2):e15809. doi: 10.5812/ircmj.15809. Epub 2014 Feb 8.
- Results publication: PubMed 24427348Xu WY, Wang N, Xu HT, Yuan HB, Sun HJ, Dun CL, Zhou SQ, Zou Z, Shi XY. Effects of sevoflurane and propofol on right ventricular function and pulmonary circulation in patients undergone esophagectomy. Int J Clin Exp Pathol. 2013 Dec 15;7(1):272-9. eCollection 2014.
- Results publication: PubMed 12635064Schwarzkopf K, Schreiber T, Preussler NP, Gaser E, Huter L, Bauer R, Schubert H, Karzai W. Lung perfusion, shunt fraction, and oxygenation during one-lung ventilation in pigs: the effects of desflurane, isoflurane, and propofol. J Cardiothorac Vasc Anesth. 2003 Feb;17(1):73-5. doi: 10.1053/jcan.2003.13.
- Results publication: PubMed 7661356Loer SA, Scheeren TW, Tarnow J. Desflurane inhibits hypoxic pulmonary vasoconstriction in isolated rabbit lungs. Anesthesiology. 1995 Sep;83(3):552-6. doi: 10.1097/00000542-199509000-00014.
- Results publication: PubMed 9689269Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x.
- Results publication: PubMed 2200486Eisenkraft JB. Effects of anaesthetics on the pulmonary circulation. Br J Anaesth. 1990 Jul;65(1):63-78. doi: 10.1093/bja/65.1.63. No abstract available.
- Results publication: PubMed 25587641Lumb AB, Slinger P. Hypoxic pulmonary vasoconstriction: physiology and anesthetic implications. Anesthesiology. 2015 Apr;122(4):932-46. doi: 10.1097/ALN.0000000000000569.
- Results publication: PubMed 27645688Dunham-Snary KJ, Wu D, Sykes EA, Thakrar A, Parlow LRG, Mewburn JD, Parlow JL, Archer SL. Hypoxic Pulmonary Vasoconstriction: From Molecular Mechanisms to Medicine. Chest. 2017 Jan;151(1):181-192. doi: 10.1016/j.chest.2016.09.001. Epub 2016 Sep 16.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional regulations. Data will be securely stored and used solely for the purposes of this study and related scientific publications.
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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.
Elif Oral Ahiskalioglu, Professor principal investigator
Ataturk 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 Total Intravenous Anesthesia (TIVA) Group, Balanced Anesthesia (BAL) Group and Combined Intravenous Volatile Anesthesia in people with VATS and Video Assisted Thoracoscopic Surgery, run by Ataturk 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 4 inclusion and 5 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 14 May 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?
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?
Malondialdehyde levels in perioperatively collected blood samples (time frame: Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation). The study lists 4 primary outcomes in all. 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 NCT07271472, 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 14 May 2026.