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Completed

NCT Number: NCT03814577

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sedat Akbas

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Antioxidant Status

Diagnostic Test

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 Oxidant Status

Diagnostic Test

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.

Bispectral Index

Device

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.

Invasive arterial monitorization

Other

Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.

Primary outcomes

  1. Total Antioxidant Status

    Time frame: Total Antioxidant Status 15 minutes before the anesthesia (preoperative period)

    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.

  2. Total Antioxidant Status

    Time frame: Total Antioxidant Status during the anesthesia (perioperative period, 60 minutes after the anesthesia induction)

    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.

  3. Total Antioxidant Status

    Time frame: Total Antioxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery)

    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.

  4. Total Oxidant Status

    Time frame: 120 minutes

    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.

  5. Total Oxidant Status

    Time frame: Total Oxidant Status during the anesthesia (perioperative period, 60 minutes after the anesthesia induction)

    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.

  6. Total Oxidant Status

    Time frame: Total Oxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery)

    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.

Secondary outcomes

  1. Heart rate

    Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours]

    Heart rate (beat/min)

  2. Mean Arterial Pressure

    Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

    Mean Arterial Pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Acronym: OxSys

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2019
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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