A Comparison of the Effects of Desflurane and TIVA on Antioxidant System in Morbidly Obese Patients

Study Overview
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Brief Summary
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With the development of technology, the safety of anesthesia devices and the progression of monitoring techniques affect the anesthetic management. There are some disadvantages such as high cost of inhalation anesthetics and long postoperative recovery time. The effects of total intravenous anesthesia (TIVA), which has been used for many years and whose positive aspects are well known, on antioxidant system in high risk patients such as morbid obese should be investigated. The aim of this study was to compare the effects of desflurane anesthesia and total intravenous anesthesia (TIVA) on the antioxidant system in morbidly obese patients undergoing bariatric surgery.

Detailed Description
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Obesity is a chronic disease that negatively affects the quality and duration of life. It is one of the most important health problem in the world and very common in Turkey. Morbid obesity operations have started to be performed frequently in our country with the effective results obtained with the continuation of weight loss after being widely applied in Europe and the United States. In our country, with the increase of obesity, laparoscopic bariatric is preferred especially with low complication rates. Inhalation anesthesia is still a major source of chemical hazard in the hospital environment due to the widespread use in operating rooms. Factors affecting the presence of anesthetic gases in the environment; device leakage, ventilation, fresh gas flow and operation of the air wasting system. Long-term exposure to anesthetic gases is known to adversely affect the health of the workers in the operating room. It has been shown that many anesthetic agents produce free radicals and alter serum antioxidant levels in patients. Antioxidant enzymes clean free radicals. Free radicals induced by various diseases can trigger oxidative stress and result in increased oxidative products. It was reported that particularly desflurane induced oxidative stress and increased oxidative products. At the same time, it was reported that desflurane triggered local and systemic oxidative stress in the experimental studies, but propofol had antioxidant properties. With the development of technology, the safety of anesthesia devices and the progression of monitoring techniques affect the anesthetic management. There are some disadvantages such as high cost of inhalation anesthetics and long postoperative recovery time. The effects of total intravenous anesthesia (TIVA), which has been used for many years and whose positive aspects are well known, on antioxidant system in high risk patients such as morbid obese should be investigated. The aim of this study was to compare the effects of desflurane anesthesia and total intravenous anesthesia (TIVA) on the antioxidant system in morbidly obese patients undergoing bariatric surgery.

Official Title
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A Comparison of the Effects of Desflurane and Total Intravenous Anesthesia (TIVA) on Antioxidant System in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Trial

Conditions
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Oxidative Stress, Morbid Obesity

Intervention / Treatment
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* Diagnostic Test: Total Antioxidant Status
* Diagnostic Test: Total Oxidant Status
* Device: Bispectral Index
* Other: Invasive arterial monitorization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology score I-III, 18-65 years, BMI> 40 Exclusion Criteria: American Society of Anesthesiology IV, Under 18 years, Over 65 years, Obstetric patients, Uncontrolled diabetes mellitus, cardiovascular and pulmonary disease, Cerebrovascular disease, Patients who refused informed consent forms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Clinical Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desflurane<br>Anesthesia will be maintained with Desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen air mixture.Total Intravenous Anesthesia will not be used in this group. While target desflurane minimum alveolar concentration (MAC) will be 1-1.5 and Bispectral Index values will be between 40-60, the flow rate will be adjusted to 2 L/min. Total Antioxidant Status and Total Oxidant Status will be then measured. Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples. | Diagnostic Test: Total Antioxidant Status<br>* Total Antioxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre.<br>Diagnostic Test: Total Oxidant Status<br>* Total Oxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre.<br>Device: Bispectral Index<br>* Bispectral Index is a method for depth of anesthesia and assessment of sedation. The values of bispectral index decreases with the deepening of anesthesia. The values of 40-60 characterize the appropriate depth of anesthesia.<br>Other: Invasive arterial monitorization<br>* Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.<br>|
| Experimental: Total Intravenous Anesthesia<br>Total Intravenous Anesthesia: Anesthesia will be maintained with inhalation with a flow of 2 L/min in 0.5 O2 oxygen air mixture. Desflurane will not be used in this group. Total Intravenous Anesthesia (propofol and remifentanyl infusion) will be performed to the patients while target Bispectral Index values were between 40-60. Also the flow rate will be adjusted to 2 L/min. Total Antioxidant Status and Total Oxidant Status will be then measured. Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples. | Diagnostic Test: Total Antioxidant Status<br>* Total Antioxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre.<br>Diagnostic Test: Total Oxidant Status<br>* Total Oxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre.<br>Device: Bispectral Index<br>* Bispectral Index is a method for depth of anesthesia and assessment of sedation. The values of bispectral index decreases with the deepening of anesthesia. The values of 40-60 characterize the appropriate depth of anesthesia.<br>Other: Invasive arterial monitorization<br>* Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Antioxidant Status | Total Antioxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre. | Total Antioxidant Status 15 minutes before the anesthesia (preoperative period) | 
| Total Antioxidant Status | Total Antioxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre. | Total Antioxidant Status during the anesthesia (perioperative period, 60 minutes after the anesthesia induction) | 
| Total Antioxidant Status | Total Antioxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre. | Total Antioxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery) | 
| Total Oxidant Status | Total Oxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre. | 120 minutes | 
| Total Oxidant Status | Total Oxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre. | Total Oxidant Status during the anesthesia (perioperative period, 60 minutes after the anesthesia induction) | 
| Total Oxidant Status | Total Oxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre. | Total Oxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate (beat/min) | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours] | 
| Mean Arterial Pressure | Mean Arterial Pressure (mmHg) | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anesthesia, Inhalation anesthetics, Total Intravenous anesthesia, Oxidative Stress, Morbid Obesity