Oxidative StressNCT04310748
Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia
A study testing Total Intravenous Anesthesia(TIVA) and Inhalation Anesthesia in people with Oxidative Stress and Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Total intravenous anesthesia (TIVA) and inhalation anesthesia are two anesthesia methods that can be preferred for the maintenance of anesthesia. Sevoflurane and propofol are drugs used frequently in these methods. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Anesthesia
- What is being tested?
- Total Intravenous Anesthesia(TIVA) and Inhalation Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 10 Jan 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages of 18-55
- Who will undergo elective rhinoplasty
- ASA Physical Status Classification System 1
Who cannot join
- Patients with a history of smoking,
- Patients with a history alcohol use
- Patients with a history drug use,
- Body Mass Index (BMI)>30
- Patients with allergies to drugs to be used
- Patients who refused to participate in the study Termination Criteria
- Whose blood pressure values are out of the targets determined in 3 consecutive measurements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Fatih, Istanbul, 34093
About this study
Total intravenous anesthesia (TIVA) and inhalation anesthesia are two anesthesia methods that can be preferred for the maintenance of anesthesia. Sevoflurane and propofol are drugs used frequently in these methods. This study aims to investigate and compare the effects of inhalation anesthesia using sevoflurane and TIVA using propofol on oxidative stress in patients undergoing controlled hypotensive anesthesia.
Read the detailed description
Controlled hypotension is defined as keeping systolic blood pressure in the range of 80-90 mmHg or mean arterial pressure in the range of 50-65 mmHg. Pharmacological and non-pharmacological methods can be used to achieve controlled hypotension. Intravenous anesthetics, inhalation anesthetics, opioids, calcium channel blockers, beta blockers, nitrate derivatives are frequently used drugs for this purpose.
General anesthesia maintenance is applied in two ways: total intravenous anesthesia (TIVA) and inhalation anesthesia. The pharmacokinetic and pharmacodynamic properties of drugs used in both methods are quite different.
Products of the body's oxidant antioxidant balance can be measured by biochemical methods and information about this balance can be obtained. Thiols are the regions of proteins most susceptible to oxidation, and the conversion of thiols to disulfides and oxyacids is the earliest marker of radical-mediated protein oxidation.
Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants.
In this study, it was aimed to investigate and compare the effects of inhalation anesthesia using sevoflurane and total intravenous anesthesia using propofol on oxidative stress in rhinoplasty cases under controlled hypotension. This assessment was planned using TAS (total antioxidant status), TOS (total oxidant status), Catalase, Myeloperoxidase (MPO), Total Thiol, Native Thiol and Disulfide parameters.
- Conditions
- Oxidative Stress, Anesthesia
- Being tested
- Total Intravenous Anesthesia(TIVA), Inhalation Anesthesia
- Keywords
- Total intravenous anesthesia (TIVA), inhalation anesthesia, Thiol-disulphide, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Intravenous Anesthesia(TIVA)Drug
Also called Group 1
Ventilation of the patients was provided with a mixture of 40% oxygen and 60% air. Along with induction, propofol at a dose of 6-10 mg/kg/hour and remifentanil infusion at a dose of 0.3-0.4 mcg/kg/min were started for the maintenance of anesthesia. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia.
The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. The surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded
Inhalation AnesthesiaDrug
Also called Group 2
Ventilation of the patients was provided with a mixture of 40% oxygen and 60% N2O. As soon as mechanical ventilation started, sevoflurane was opened at a concentration of 2-3% with a MAK value of 1.1-1.3. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia.
The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. At the end of the surgery, the surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia(TIVA) | Active comparator | Anesthesia is maintaining with TIVA (Group 1) Receives: Drug: Total Intravenous Anesthesia(TIVA) |
| Inhalation Anesthesia | Active comparator | Anesthesia is maintaining with inhalation anesthesia (Group 2) Receives: Drug: Inhalation Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAS (TOTAL ANTIOXIDANE STATUS)
Evaluation of the effect of anesthesia technique on oxidative stress by TAS values Plasma TAS levels are measured by a commercial mass developed by Erel. Plasma TAS values are expressed in millimeters with the Trolox value per liter.
3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Measured: Change from Baseline TAS levels at 2 hours
TOS (TOTAL OXIDANE STATUS)
Evaluation of the effect of anesthesia technique on oxidative stress by TOS values Measurement for TOS is calibrated with hydrogen peroxide and the results are expressed in micromolar by the hydrogen peroxide value per liter (mmol H2O2 equiv / L).
3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Measured: Change from Baseline TOS levels at 2 hours
Catalase
Evaluation of the effect of anesthesia technique on oxidative stress by catalase values The catalase enzyme converts H2O2 into water and oxygen. Catalase enzyme activity decreases in the amount of H2O2 as a result of the dismutase reaction shown by the enzyme in an environment containing H2O2. Catalase enzyme activity is determined by measuring the change in H2O2 concentration at 240 nm. Unit: Unite / L.
3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Measured: Change from Baseline Catalase levels at 2 hours
Myeloperoxidase
Evaluation of the effect of anesthesia technique on oxidative stress by Myeloperoxidase values Myeloperoxidase activity is determined by measuring the orange color of o-Dianisidine molecule in oxidized environment with H2O2 at 444 nm colorimetrically. The result is calculated using the molar absorption coefficient of the oxidized o-Dianisidine molecule and defined as Unite / L.
3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Measured: Change from Baseline Myeloperoxidase levels at 2 hours
Parameters of Thiol- Disulphide Homeostasis
Evaluation of the effect of anesthesia technique on oxidative stress by Thiol - Disulphide Homeostasis values Extra reduction of DTNB and further reduction of the disulfide bond produced after the DTNB reaction are prevented. The total thiol content of the sample is measured at 410 nm using the modified Ellman reagent. Native thiol content is subtracted from the total thiol content and half of the difference obtained gives the amount of disulfide bond. Unit: μmol / L.
3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Measured: Change from Baseline Thiol- Disulphide levels at 2 hours
Secondary outcomes (2)
Surgical Satisfaction: score
At the end of the surgery surgeons evaluated surgical satisfaction. the investigators used surgeon satisfaction score which one is performing like that 1- bad 2-moderate 3-good 4-excellent
Measured: postoperative 1 minute
Bleeding Scores
At the end of the surgery surgeons evaluated bleeding scores. the investigators used bleeding score which one is performing like that 0-No bleeding 1-minor bleeding no aspiration required 2- Minor bleeding, aspiration required 3- minor bleeding, frequent aspiration required, 4-Moderate bleeding, visible only with aspiration 5- Severe bleeding,
Measured: postoperative 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 May 2020
- Primary completion1 Oct 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- This study is a randomized controlled prospective study to be performed in 60 patients ASA 1 between the ages of 18-55 who will undergo elective rhinoplasty. History of smoking, alcohol, and drug use, who had a BMI\>30 are excluding from the study. BIS and TOF monitoring are performing in all patients undergoing standard anesthesia induction. Patients divided into two groups with closed envelope method; TIVA(Group1) and inhalation anesthesia(Group2). In both, MAP target is determining to be in the range of 50-65 mmHg. Blood sample is collecting and storing to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters, before induction and 5, 30, 60 and 120 minutes after induction. The extubation time is recording. The surgical field opinion and satisfaction assessment and the survey presented to the surgeon, respectively. The patients by following up in the recovery unit for 30 minutes; numerical pain scores and nausea-vomiting scores is recording.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Nur İncekara, Bezmialem Vakif University
- Investigators
- Kazım Karaaslan, MD, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310748
- Sponsor's protocol ID
- Zeynep01
- Status last verified
- Nov 2021
- First submitted
- 6 Mar 2020
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia
- ClinicalTrials.gov ID
- NCT04310748
- Acronym / sponsor ID
- Zeynep01
- Conditions
- Oxidative Stress, Anesthesia
- Keywords
- Total intravenous anesthesia (TIVA), inhalation anesthesia, Thiol-disulphide, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 17 Mar 2020 (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.
Total intravenous anesthesia (TIVA) and inhalation anesthesia are two anesthesia methods that can be preferred for the maintenance of anesthesia. Sevoflurane and propofol are drugs used frequently in these methods. This study aims to investigate and compare the effects of inhalation anesthesia using sevoflurane and TIVA using propofol on oxidative stress in patients undergoing controlled hypotensive anesthesia.
Detailed description
Controlled hypotension is defined as keeping systolic blood pressure in the range of 80-90 mmHg or mean arterial pressure in the range of 50-65 mmHg. Pharmacological and non-pharmacological methods can be used to achieve controlled hypotension. Intravenous anesthetics, inhalation anesthetics, opioids, calcium channel blockers, beta blockers, nitrate derivatives are frequently used drugs for this purpose.
General anesthesia maintenance is applied in two ways: total intravenous anesthesia (TIVA) and inhalation anesthesia. The pharmacokinetic and pharmacodynamic properties of drugs used in both methods are quite different.
Products of the body's oxidant antioxidant balance can be measured by biochemical methods and information about this balance can be obtained. Thiols are the regions of proteins most susceptible to oxidation, and the conversion of thiols to disulfides and oxyacids is the earliest marker of radical-mediated protein oxidation.
Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants.
In this study, it was aimed to investigate and compare the effects of inhalation anesthesia using sevoflurane and total intravenous anesthesia using propofol on oxidative stress in rhinoplasty cases under controlled hypotension. This assessment was planned using TAS (total antioxidant status), TOS (total oxidant status), Catalase, Myeloperoxidase (MPO), Total Thiol, Native Thiol and Disulfide parameters.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a randomized controlled prospective study to be performed in 60 patients ASA 1 between the ages of 18-55 who will undergo elective rhinoplasty. History of smoking, alcohol, and drug use, who had a BMI>30 are excluding from the study. BIS and TOF monitoring are performing in all patients undergoing standard anesthesia induction. Patients divided into two groups with closed envelope method; TIVA(Group1) and inhalation anesthesia(Group2). In both, MAP target is determining to be in the range of 50-65 mmHg. Blood sample is collecting and storing to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters, before induction and 5, 30, 60 and 120 minutes after induction. The extubation time is recording. The surgical field opinion and satisfaction assessment and the survey presented to the surgeon, respectively. The patients by following up in the recovery unit for 30 minutes; numerical pain scores and nausea-vomiting scores is recording.
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia(TIVA) | Active comparator | Drug: Total Intravenous Anesthesia(TIVA)Anesthesia is maintaining with TIVA (Group 1) |
| Inhalation Anesthesia | Active comparator | Drug: Inhalation AnesthesiaAnesthesia is maintaining with inhalation anesthesia (Group 2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages of 18-55
- Who will undergo elective rhinoplasty
- ASA Physical Status Classification System 1
Key exclusion criteria (7 listed)
- Patients with a history of smoking,
- Patients with a history alcohol use
- Patients with a history drug use,
- Body Mass Index (BMI)>30
- Patients with allergies to drugs to be used
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 Intravenous Anesthesia(TIVA)Also: Group 1Ventilation of the patients was provided with a mixture of 40% oxygen and 60% air. Along with induction, propofol at a dose of 6-10 mg/kg/hour and remifentanil infusion at a dose of 0.3-0.4 mcg/kg/min were started for the maintenance of anesthesia. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia. The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. The surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded | Drug | Total Intravenous Anesthesia(TIVA) |
| Inhalation AnesthesiaAlso: Group 2Ventilation of the patients was provided with a mixture of 40% oxygen and 60% N2O. As soon as mechanical ventilation started, sevoflurane was opened at a concentration of 2-3% with a MAK value of 1.1-1.3. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia. The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. At the end of the surgery, the surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded. | Drug | Inhalation Anesthesia |
Primary outcome
TAS (TOTAL ANTIOXIDANE STATUS)
Time frame: Change from Baseline TAS levels at 2 hours
Evaluation of the effect of anesthesia technique on oxidative stress by TAS values Plasma TAS levels are measured by a commercial mass developed by Erel. Plasma TAS values are expressed in millimeters with the Trolox value per liter. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
TOS (TOTAL OXIDANE STATUS)
Time frame: Change from Baseline TOS levels at 2 hours
Evaluation of the effect of anesthesia technique on oxidative stress by TOS values Measurement for TOS is calibrated with hydrogen peroxide and the results are expressed in micromolar by the hydrogen peroxide value per liter (mmol H2O2 equiv / L). 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Catalase
Time frame: Change from Baseline Catalase levels at 2 hours
Evaluation of the effect of anesthesia technique on oxidative stress by catalase values The catalase enzyme converts H2O2 into water and oxygen. Catalase enzyme activity decreases in the amount of H2O2 as a result of the dismutase reaction shown by the enzyme in an environment containing H2O2. Catalase enzyme activity is determined by measuring the change in H2O2 concentration at 240 nm. Unit: Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Myeloperoxidase
Time frame: Change from Baseline Myeloperoxidase levels at 2 hours
Evaluation of the effect of anesthesia technique on oxidative stress by Myeloperoxidase values Myeloperoxidase activity is determined by measuring the orange color of o-Dianisidine molecule in oxidized environment with H2O2 at 444 nm colorimetrically. The result is calculated using the molar absorption coefficient of the oxidized o-Dianisidine molecule and defined as Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Parameters of Thiol- Disulphide Homeostasis
Time frame: Change from Baseline Thiol- Disulphide levels at 2 hours
Evaluation of the effect of anesthesia technique on oxidative stress by Thiol - Disulphide Homeostasis values Extra reduction of DTNB and further reduction of the disulfide bond produced after the DTNB reaction are prevented. The total thiol content of the sample is measured at 410 nm using the modified Ellman reagent. Native thiol content is subtracted from the total thiol content and half of the difference obtained gives the amount of disulfide bond. Unit: μmol / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
2 secondary outcomes
Surgical Satisfaction: score
Time frame: postoperative 1 minute
Bleeding Scores
Time frame: postoperative 1 minute
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 15 Nov 2021.
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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.
Kazım Karaaslan, MD study chair
Bezmialem Vakif University
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 Intravenous Anesthesia(TIVA) and Inhalation Anesthesia in people with Oxidative Stress and Anesthesia, run by Bezmialem Vakif 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 15 Nov 2021. 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?
TAS (TOTAL ANTIOXIDANE STATUS) (time frame: Change from Baseline TAS levels at 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.