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

NCT03814577 | Completed

• 1 other identifier: sedatakbas6
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxidative Stress; Morbid Obesity

Keywords

General anesthesia; Inhalation anesthetics; Total Intravenous anesthesia; Oxidative Stress; Morbid Obesity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Heart rate

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

• Mean Arterial Pressure

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

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

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; Diagnostic Test: Total Oxidant Status; Device: Bispectral Index; Other: Invasive arterial monitorization

Total Intravenous Anesthesia

EXPERIMENTAL

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; Diagnostic Test: Total Oxidant Status; Device: Bispectral Index; Other: Invasive arterial monitorization

Interventions

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.

Desflurane; Total Intravenous Anesthesia

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.

Desflurane; Total Intravenous Anesthesia

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.

Desflurane; Total Intravenous 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.

Desflurane; Total Intravenous Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology score I-III,
• years,
• BMI\> 40

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Sedat Akbas

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

Location

Related Publications (1)

• 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.

  PMID: 26136976 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Sedat Akbas, Asst. Prof.

  Inonu University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Investigator)
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr. Sedat Akbas

Model Details: Prospective Randomized Clinical Study

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 24, 2019
• Study Start: January 24, 2019
• Primary Completion: June 21, 2019
• Study Completion: July 21, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)