Total Intravenous Anesthesia (TIVA), Combined Intravenous-Volatile Anesthesia (CIVA), and Balanced Anesthesia (BAL) on Perioperative Oxidative Stress in Video-Assisted Thoracoscopic Surgery (VATS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Malondialdehyde levels in perioperatively collected blood samples
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Total Intravenous Anesthesia (TIVA) Group (Drug)
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.
干预措施: Balanced Anesthesia (BAL) Group (Drug)
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.
干预措施: Combined Intravenous Volatile Anesthesia (Drug)
结局指标
主要结局
Malondialdehyde levels in perioperatively collected blood samples
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Postoperative nausea and vomiting(From 1 to 24 hour post operatively)
- Partial pressure of carbon dioxide pressure (PaCO₂)(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 oxygen (PaO₂) values(During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation)
研究者
Elif Oral Ahiskalioglu
Principal Investigator
Ataturk University
