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

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Oxidative Stress
• Intervention / Treatment: Diagnostic test: Total Antioxidant Status; Diagnostic test: Total Oxidant Status; Device: Bispectral Index; Other: Invasive arterial monitorization

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye-Türkçe
    • Malatya, Türkiye-Türkçe, Turkey, 44090
      • Sedat Akbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Desflurane; 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; 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.; Diagnostic test: 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.; Device: Bispectral Index; 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.; Other: Invasive arterial monitorization; Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.
EXPERIMENTAL: Total Intravenous Anesthesia; 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; 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.; Diagnostic test: 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.; Device: Bispectral Index; 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.; Other: Invasive arterial monitorization; Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Sedat Akbas, Asst. Prof., Inonu University Medical Faculty

Publications and helpful links

General Publications

• Han C, Ding W, Jiang W, Chen YU, Hang D, Gu D, Jiang G, Tan Y, Ge Z, Ma T. A comparison of the effects of midazolam, propofol and dexmedetomidine on the antioxidant system: A randomized trial. Exp Ther Med. 2015 Jun;9(6):2293-2298. doi: 10.3892/etm.2015.2410. Epub 2015 Apr 7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2019
• Primary Completion (ACTUAL): June 21, 2019
• Study Completion (ACTUAL): July 21, 2019

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (ACTUAL): January 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Morbid Obesity; Oxidative Stress; General anesthesia; Inhalation anesthetics; Total Intravenous anesthesia
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: sedatakbas6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No