Oxidative StressOxSysNCT03814577
A Comparison of the Effects of Desflurane and TIVA on Antioxidant System in Morbidly Obese Patients
A study testing Total Antioxidant Status, Total Oxidant Status and Bispectral Index in people with Oxidative Stress and Morbid Obesity, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oxidative Stress, Morbid Obesity
- What is being tested?
- Total Antioxidant Status, Total Oxidant Status and Bispectral Index
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2019to 21 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology score I-III,
- 18-65 years,
- BMI> 40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Oxidative Stress, Morbid Obesity
- Being tested
- Total Antioxidant Status, Total Oxidant Status, Bispectral Index, Invasive arterial monitorization
- Keywords
- General anesthesia, Inhalation anesthetics, Total Intravenous anesthesia, Oxidative Stress, Morbid Obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Antioxidant StatusDiagnostic 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 StatusDiagnostic 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 IndexDevice
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 monitorizationOther
Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Total Antioxidant Status; Diagnostic Test: Total Oxidant Status; Device: Bispectral Index; Other: Invasive arterial monitorization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Total Oxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery)
Secondary outcomes (2)
Heart rate
Heart rate (beat/min)
Measured: 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)
Measured: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start24 Jan 2019
- Primary completion21 Jun 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Clinical Study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedat AKBAS, Inonu University
- Investigators
- Sedat Akbas, Asst. Prof., Principal investigator, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814577
- Sponsor's protocol ID
- sedatakbas6
- Acronym
- OxSys
- Status last verified
- Aug 2019
- First submitted
- 7 Jan 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26136976
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03814577
- Acronym / sponsor ID
- OxSys / sedatakbas6
- Conditions
- Oxidative Stress, Morbid Obesity
- Keywords
- General anesthesia, Inhalation anesthetics, Total Intravenous anesthesia, Oxidative Stress, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Active comparator | Diagnostic Test: Total Antioxidant Status, Diagnostic Test: Total Oxidant Status, Device: Bispectral Index, Other: Invasive arterial monitorizationAnesthesia 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. |
| Total Intravenous Anesthesia | Experimental | Diagnostic Test: Total Antioxidant Status, Diagnostic Test: Total Oxidant Status, Device: Bispectral Index, Other: Invasive arterial monitorizationTotal 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology score I-III,
- 18-65 years,
- BMI> 40
Key exclusion criteria (7 listed)
- American Society of Anesthesiology IV,
- Under 18 years,
- Over 65 years,
- Obstetric patients,
- Uncontrolled diabetes mellitus, cardiovascular and pulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Antioxidant StatusTotal 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 | Desflurane, Total Intravenous Anesthesia |
| Total Oxidant StatusTotal 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. | Diagnostic test | Desflurane, Total Intravenous Anesthesia |
| Bispectral IndexBispectral 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. | Device | Desflurane, Total Intravenous Anesthesia |
| Invasive arterial monitorizationInvasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples. | Other | Desflurane, Total Intravenous Anesthesia |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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]
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Background: PubMed 26136976Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sedat Akbas, Asst. Prof. principal investigator
Inonu University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Antioxidant Status, Total Oxidant Status and Bispectral Index in people with Oxidative Stress and Morbid Obesity, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Antioxidant Status (time frame: Total Antioxidant Status 15 minutes before the anesthesia (preoperative period)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.