Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TOS
研究概览
简要总结
The aim of this study to evaluate the patients who underwent controlled hypotensive anesthesia under standardized depth of anesthesia with total intravenous anesthesia or inhalation anesthesia; preoperative and 30. ,60. ,120. second of intraoperative period blood HIF 1a, TAS, TOS measurement and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which hypotensive anesthesia technique is related.
详细描述
Controlled hypotension is the voluntary reversible reduction of arterial blood pressure. Hypotensive anesthesia is a method of anesthesia in which blood pressure is reduced in a controlled manner, especially in certain surgeries. İt reduces intraoperative bleeding and need for blood transfusion and provides a clean surgical vision in narrow-field surgeries or with high bleeding potential. Hypotensive anesthesia can be performed according to mean blood pressure (MBP) or systolic blood pressure (SBP).
A non-invasive cerebral oximeter is used to see the changes in the brain due to high oxygen-dependent metabolism during induction and maintenance of anesthesia.
Hypoxia inducible factor (HIF) is a transcription factor involved in cell adaptation mechanism activated in response to hypoxia.
The biological activity of HIF 1 is determined by the expression and activity of the HIF 1a subunit.
Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
The investigators divided the patients to two groups. Patients were divided into two groups with a lottery. Surgeons did not know which hypotensive anesthesia technique were used. And surgeons evaluated surgical satisfaction and bleeding scores
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-55 years old
- •ASA Physical Status Classification System 1
- •Undergoing to Elective rhinoplasty
排除标准
- •Patients have any autoimmune disease
- •Smoking of patients
- •Development of any allergic reaction during the procedure
- •Failure to collect blood to be examined at the appropriate time
- •Body mass index is less than 19 or greater than 30
- •Termination criteria
- •Development of severe hypotension and bradycardia during measurements
- •Development of severe drug allergy during follow-up
- •In the event of any complications related to the surgical procedure
研究组 & 干预措施
Total intravenous anesthesia technique for group 1 patients
Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 6-10 mg / kg / h propofol and 0.0,4mcg / kg remifentanyl infusion / min. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.
Hemodynamic parameters (HR, SBP, OCD), BIS,TOF and SpO2 were recorded at 5 minute intervals.
Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory
干预措施: Mean Blood Pressure (MBP) (Procedure)
Total intravenous anesthesia technique for group 1 patients
Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 6-10 mg / kg / h propofol and 0.0,4mcg / kg remifentanyl infusion / min. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.
Hemodynamic parameters (HR, SBP, OCD), BIS,TOF and SpO2 were recorded at 5 minute intervals.
Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory
干预措施: Add to 0.5 mcg / kg fentanyl. (Drug)
Inhalation anesthesia technique for group 2 patients
Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA to provide a value of BIS between 40-60. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.
Hemodynamic parameters (HR, SBP, OCD), BIS,TOF and SpO2 were recorded at 5 minute intervals.
Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory
干预措施: Mean Blood Pressure (MBP) (Procedure)
Inhalation anesthesia technique for group 2 patients
Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA to provide a value of BIS between 40-60. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.
Hemodynamic parameters (HR, SBP, OCD), BIS,TOF and SpO2 were recorded at 5 minute intervals.
Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory
干预措施: Add to 0.5 mcg / kg fentanyl. (Drug)
结局指标
主要结局
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TOS
时间窗: Change from Baseline TOS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
Measurement for TOS is calibrated with hydrogen peroxide and the results are expressed in micromolar by the hydrogen peroxide value per liter (mmol H2O2 equiv / L).5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by HIF1a
时间窗: Change from Baseline HIF 1a 30th minute (t1), 1st hour (t2) and 2st hour (t3)
Under normoxic conditions, HIF 1a protein can hardly be detected, but when hypoxia starts, its expression starts within 2 minutes and peaks at 4-8 hours of hypoxia. 5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TAS
时间窗: Change from Baseline TAS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
Plasma TAS and TOS levels are measured with a commercial kit developed by Erel. Values for plasma TAS are expressed in millimeters by the Trolox value per liter. 5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.
次要结局
- surgical satisfaction(postoperative 1 minute)
- anesthetic consumption for group 1 propofol consumption (mg) and remifentanyl consumption(microgram)(postoperative 1 minute)
- bleeding scores(postoperative 1 minute)
- anesthetic consumption for group 2 N2O2 consumption (ml) and sevoflurane consumption (ml)(postoperative 1 minute)