Oxidative StressNCT03563833
Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and StO2 in Hypotensive Anesthesia Applications
A study testing Minimal Flow Anesthesia and High Flow Anesthesia in people with Oxidative Stress, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Minimal Flow Anesthesia and High Flow Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2018to 30 Nov 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,
- ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,
Who cannot join
- operations in less than one hour
- uncontrolled hypertension
- DM (Diabetes Mellitus)
- cerebrovascular disease
- coagulopathy
- morbid obesity ((BMI ≥ 35)
- renal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdoğan University Training and Research Hospital
Rize, 53200
Şule Batçık, Asst. Prof.
About this study
Official title: Investigation of the Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and Peripheral Tissue Saturation (StO2) in Hypotensive Anesthesia Applications
The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.
Read the detailed description
The oxidative stress at the cellular level and the possible effects of general anesthesia techniques on the antioxidant system make the method of anesthesia more important.
The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.
Minimal flow anesthesia is widely used because of its advantages such as cost reduction, prevention of environmental pollution, minimization of heat and humidity loss.
Hypotensive anesthesia is preferred in some specialized surgical procedures in order to reduce bleeding and improve the surgical field of view.
The use of hypotensive anesthesia and inhalation agents may cause hypoperfusion at the tissue level and cause hypoxia-induced oxidative stress and initiate cell damage.
Determining the ideal anesthesia technique in terms of oxidative stress and tissue perfusion will reduce intra- and postoperative risks by protecting patients from the harmful effects of anesthesia.
- Conditions
- Oxidative Stress
- Being tested
- Minimal Flow Anesthesia, High Flow Anesthesia
- Keywords
- Minimal Flow Anesthesia, Thiol/disulfide balance, Tissue oxygen saturation, hypotensive anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Flow AnesthesiaOther
Minimal Flow Anesthesia with 0,4 L min-1
High Flow AnesthesiaOther
High Flow Anesthesia with 2 L min-1
| Study group | Role | What they receive |
|---|---|---|
| Minimal Flow Anesthesia | Other | Minimal Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5). In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg.
Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al. Receives: Other: Minimal Flow Anesthesia |
| High Flow Anesthesia | Other | High Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5) In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg.
Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al. Receives: Other: High Flow Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiol Disulfide Balance
Change of Oxidative Stress Marker
Measured: For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery
Secondary outcomes (1)
StO2
Change of Peripheral Tissue Oxygen Saturation
Measured: For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start4 May 2018
- Primary completion31 Oct 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şule Batçık, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Şule Batçık, Asst. Prof., Principal investigator, Recep Tayyip Erdoğan University Medical School Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563833
- Sponsor's protocol ID
- 2018/64
- Status last verified
- Jun 2018
- First submitted
- 20 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and Peripheral Tissue Saturation (StO2) in Hypotensive Anesthesia Applications
- ClinicalTrials.gov ID
- NCT03563833
- Acronym / sponsor ID
- 2018/64
- Conditions
- Oxidative Stress
- Keywords
- Minimal Flow Anesthesia, Thiol/disulfide balance, Tissue oxygen saturation, hypotensive anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 20 Jun 2018 (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.
The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.
Detailed description
The oxidative stress at the cellular level and the possible effects of general anesthesia techniques on the antioxidant system make the method of anesthesia more important.
The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.
Minimal flow anesthesia is widely used because of its advantages such as cost reduction, prevention of environmental pollution, minimization of heat and humidity loss.
Hypotensive anesthesia is preferred in some specialized surgical procedures in order to reduce bleeding and improve the surgical field of view.
The use of hypotensive anesthesia and inhalation agents may cause hypoperfusion at the tissue level and cause hypoxia-induced oxidative stress and initiate cell damage.
Determining the ideal anesthesia technique in terms of oxidative stress and tissue perfusion will reduce intra- and postoperative risks by protecting patients from the harmful effects of anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Flow Anesthesia | Other | Other: Minimal Flow AnesthesiaMinimal Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5). In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg. Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al. |
| High Flow Anesthesia | Other | Other: High Flow AnesthesiaHigh Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5) In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg. Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,
- ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,
Key exclusion criteria (7 listed)
- operations in less than one hour
- uncontrolled hypertension
- DM (Diabetes Mellitus)
- cerebrovascular disease
- coagulopathy
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 |
|---|---|---|
| Minimal Flow AnesthesiaMinimal Flow Anesthesia with 0,4 L min-1 | Other | Minimal Flow Anesthesia |
| High Flow AnesthesiaHigh Flow Anesthesia with 2 L min-1 | Other | High Flow Anesthesia |
Primary outcome
Thiol Disulfide Balance
Time frame: For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery
Change of Oxidative Stress Marker
1 secondary outcome
StO2
Time frame: For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- 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.
Şule Batçık, Asst. Prof. principal investigator
Recep Tayyip Erdoğan University Medical School Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Flow Anesthesia and High Flow Anesthesia in people with Oxidative Stress, run by Recep Tayyip Erdogan University Training and Research Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şule Batçık, Asst. Prof. (+904642130491 ext. 2128, drsulebatcik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiol Disulfide Balance (time frame: For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery). 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 20 Jun 2018.