Laparoscopic CholecystectomyİMANCT04926480
Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and IMA in Laparoscopic Cholecystectomy Surgery
A study testing low and high flow Anesthesia in people with Laparoscopic Cholecystectomy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery In this study, our aim is to compare the effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- low and high flow Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Jan 2020to 31 Jul 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II
- Aged 18-70 years
- elective laparoscopic cholecystectomy surgery
- general anesthesia
Who cannot join
- Morbidly obese patients
- alcohol or drug addiction
- chronic obstructive pulmonary disease
- coronary artery disease
- congestive heart failure
- significant anemia
Show all 12Show fewer
- liver or kidney disease
- allergy to propofol or halogenated drugs
- respiratory system pathology, hypotension
- hypovolemia and patients with a systemic disease
- patients using drugs that may affect the oxidation system
- patients who are converted to open surgery intraoperatively and develop complications
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bursa yüksek ihtisas training and research hospital
Bursa, 16000
Bursa yüksek ihtisas
Bursa, 16000
About this study
Official title: Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
In this study, our aim is to compare the effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in laparoscopic Cholecystectomy Surgery using Sevoflurane as an anesthetic gas routinely.
Read the detailed description
General anesthesia is characterized by reversible loss of consciousness, analgesia in the whole body, amnesia, and some muscle relaxation. Induction, which is the initial phase of anesthesia, can be performed with intravenous or inhalation anesthetics. The most common practice today for maintenance of anesthesia after induction is to add an effective low intensity inhalation anesthetic to the oxygen, nitrous oxide or oxygen,air mixture. Although new inhalation agents provide some advantages over old ones, they are more costly. This situation has brought the development of new anesthetic techniques to the agenda. Interest in low fresh gas flow anesthesia methods has been increasing in recent years. The high standard of anesthesia machines, the availability of monitors that continuously analyze the anesthetic gas composition, and the increase in knowledge on the pharmacokinetics and pharmacodynamics of inhalation anesthetics have greatly facilitated the safe application of low-flow anesthesia. The term low flow anesthesia is used to describe inhalation anesthesia techniques with a semi closed rebreathing system with a reventilation rate of at least 50%, and with the help of a reversible anesthesia system, after the carbon dioxide is removed from the expired gas mixture from the patient, the metabolic requirements of the body are determined. At least 50% of the fresh oxygen flow is given back to the patient together with the volatile anesthetics in sufficient quantity. Many different anesthesia applications with different fresh gas flow rates have been described. Very high flow > 4 L / min, High flow 2-4 L / min, Medium flow 1-2 L / min, Low flow 500-1000 mL / min, Minimal flow 250-500 mL / min, Metabolic flow <250 mL / min. Currents of 1 L / min and below enter the low flow anesthesia head. The low flow anesthesia we use routinely has many advantages for the patient. Increasing the respiration rate of the humidified and warmed exhaled gas is of great importance for the function of the ciliated epithelium and for mucociliary cleaning, it provides a significant reduction in postoperative sore throat. It has an economic advantage due to the reduction in anesthetic gas consumption. It reduces exposure to anesthetic gases in the operating room environmen ; hypoxia, incompatibility of anesthesia depth, hypercarbia, possibility of heat accumulation and increased risk of bacterial contamination. Safety Features in Anesthesia Machines; According to the European common standard EN 740 conditions; They have features for monitoring inspired oxygen concentration, Monitoring of inhaled CO2 concentration, Monitoring of Volatile anesthetic concentration, Oxygen support insufficiency alarm, Oxygen bypass, Oxygen rate monitor. Although the risk is very low in low flow, oxygen in inspired fresh gas to avoid hypoxia Its concentration should be at least 50%. Depth of anesthesia can be adjusted according to the sevoflurane gas concentration in the monitor. Inspired and expired CO2 monitoring is important for patient safety. In order to prevent hypercarbia, appropriate carbon dioxide absorbent should be used and frequent replacement should be provided. Bacterial filters should also be used in the breathing circuit to prevent heat build-up and bacterial contamination. In high-flow anesthesia, drying of the respiratory tract and a decrease in mucociliary activity occurs. The use of a breathing circuit with a moisture retaining chamber and a moisture retaining filter can prevent this situation. Increasing anesthetic gas consumption increases the cost of the anesthetic gas in the surgical environment.
The use of volatile anesthetics such as desflurane or sevoflurane during general anesthesia causes an increase in lipid peroxidation or proinflammatory cytokines in macrophages, leading to generalized inflammatory reactions. It is stated that all these can cause oxidative stress, and under general anesthesia, patients are exposed to oxidative stress caused by volatile anesthetics. However, laparoscopic cholecystectomy, which has become a common procedure due to its advantages, increases the intraabdominal pressure, liver, splanchnic vessels, mesenteric hypoxia, ischemia. It causes reperfusion damage and consequently an increase in oxidative stress. Sevoflurane is a widely used anesthetic agent, its anti-inflammatory and antioxidant properties have been demonstrated in various studies, it has been shown that it protects against ischemia-reperfusion damage in vital organs such as heart, lung and kidney, and has more protective effects on thiol disulfide homeostasis than desflurane.
Thiols are compounds containing sulfur group, which are essential antioxidant buffers that interact with almost all physiological oxidants. Thiol groups are oxidized by the surrounding oxidant molecules and converted to disulfide structures and then thiol groups, thiol disulfide balance was a sustainable reaction. Thiols act as fast electron acceptors and play an important role in defending against reactive oxygen species by contributing a large part of the total antioxidants present in the body. Plasma thiols have pro-oxidant or antioxidant effects on physiological events; but they are generally regarded as antioxidants. It also plays a critical role in programmed cell death, detoxification, antioxidant protection and regulation of cellular enzymatic activity. Measuring thiols in serum may show an indirect reflection of antioxidant defense. Another oxidation parameter that can be used as a perioperative ischemia marker is ischemia-modified albumin (IMA). Hypoxia, acidosis, and superoxide radical damage cause IMA formation by altering the structure of the N terminal, reducing the binding capacity of albumin to metals. IMA is an early-rising indicator of ischemia, it increases in as little as 6 minutes. Anesthesia method, surgical method, medications used, infection and operation time affect postoperative morbidity and mortality by changing the stress response.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- low and high flow Anesthesia
- Keywords
- Low Flow, High Flow, tiyol-disülfid homeostasis, Modified Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low and high flow AnesthesiaProcedure or surgery
Also called Cholecystectomy Surgery
comparison of hemodynamic changes in low and high flow anesthesia groups
| Study group | Role | What they receive |
|---|---|---|
| low flow Anesthesia group | Experimental | Antioxidant parameters are measured in the low flow anesthesia group. Receives: Procedure: low and high flow Anesthesia |
| high flow Anesthesia gruop | Active comparator | Antioxidant parameters are measured in the high flow anesthesia group. Receives: Procedure: low and high flow Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
In order to determine thiol / disulphid homeostasis and IMA serum level, 5 ml blood samples were taken 3 times from each patient (T0: 5 minutes before induction of anesthesia, T1: 5 minutes after abdominal gas is completely evacuated, T2: 24 hours postoperatively). Serum disulfide/thiol homeostasis measurements were determined by the automated spectrophotometric method described by Erel and Neşelioğlu.Thiol/disuphide hemostasis parameters were studied with the same serum samples in the same session. Ischemia modified albumen Bar-Or et al. The study was carried out using the spectrophotometric method suggested by The IMA is specified as the absorption unit (AUC).
Measured: 24 hours after operation
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide
During the operation, heart rate beats/min were recorded on the monitor at the 5th, 10th, 15th, 30th, 45th, 60th, 90th, 120th, 150th, 180th and 210th minutes after intubation and at the end of extubation.
Measured: during peroperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start10 Jan 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, sermın emınoglu, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- umran karaca, 3, Study director, Assistant researcherasıye demirel, 4, Principal investigator, Assistant researchermehmet gamlı, 5, Principal investigator, Assistant researcheryasemin ustundag, 6, Principal investigator, Assistant researcherozcan erel, 7, Principal investigator, Assistant researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926480
- Sponsor's protocol ID
- 2011-KAEK-25 2019 /12-21
- Acronym
- İMA
- Status last verified
- Jun 2021
- First submitted
- 21 Apr 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol and results can be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT04926480
- Acronym / sponsor ID
- İMA / 2011-KAEK-25 2019 /12-21
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Low Flow, High Flow, tiyol-disülfid homeostasis, Modified Albumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Jun 2021 (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.
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
In this study, our aim is to compare the effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in laparoscopic Cholecystectomy Surgery using Sevoflurane as an anesthetic gas routinely.
Detailed description
General anesthesia is characterized by reversible loss of consciousness, analgesia in the whole body, amnesia, and some muscle relaxation. Induction, which is the initial phase of anesthesia, can be performed with intravenous or inhalation anesthetics. The most common practice today for maintenance of anesthesia after induction is to add an effective low intensity inhalation anesthetic to the oxygen, nitrous oxide or oxygen,air mixture. Although new inhalation agents provide some advantages over old ones, they are more costly. This situation has brought the development of new anesthetic techniques to the agenda. Interest in low fresh gas flow anesthesia methods has been increasing in recent years. The high standard of anesthesia machines, the availability of monitors that continuously analyze the anesthetic gas composition, and the increase in knowledge on the pharmacokinetics and pharmacodynamics of inhalation anesthetics have greatly facilitated the safe application of low-flow anesthesia. The term low flow anesthesia is used to describe inhalation anesthesia techniques with a semi closed rebreathing system with a reventilation rate of at least 50%, and with the help of a reversible anesthesia system, after the carbon dioxide is removed from the expired gas mixture from the patient, the metabolic requirements of the body are determined. At least 50% of the fresh oxygen flow is given back to the patient together with the volatile anesthetics in sufficient quantity. Many different anesthesia applications with different fresh gas flow rates have been described. Very high flow > 4 L / min, High flow 2-4 L / min, Medium flow 1-2 L / min, Low flow 500-1000 mL / min, Minimal flow 250-500 mL / min, Metabolic flow <250 mL / min. Currents of 1 L / min and below enter the low flow anesthesia head. The low flow anesthesia we use routinely has many advantages for the patient. Increasing the respiration rate of the humidified and warmed exhaled gas is of great importance for the function of the ciliated epithelium and for mucociliary cleaning, it provides a significant reduction in postoperative sore throat. It has an economic advantage due to the reduction in anesthetic gas consumption. It reduces exposure to anesthetic gases in the operating room environmen ; hypoxia, incompatibility of anesthesia depth, hypercarbia, possibility of heat accumulation and increased risk of bacterial contamination. Safety Features in Anesthesia Machines; According to the European common standard EN 740 conditions; They have features for monitoring inspired oxygen concentration, Monitoring of inhaled CO2 concentration, Monitoring of Volatile anesthetic concentration, Oxygen support insufficiency alarm, Oxygen bypass, Oxygen rate monitor. Although the risk is very low in low flow, oxygen in inspired fresh gas to avoid hypoxia Its concentration should be at least 50%. Depth of anesthesia can be adjusted according to the sevoflurane gas concentration in the monitor. Inspired and expired CO2 monitoring is important for patient safety. In order to prevent hypercarbia, appropriate carbon dioxide absorbent should be used and frequent replacement should be provided. Bacterial filters should also be used in the breathing circuit to prevent heat build-up and bacterial contamination. In high-flow anesthesia, drying of the respiratory tract and a decrease in mucociliary activity occurs. The use of a breathing circuit with a moisture retaining chamber and a moisture retaining filter can prevent this situation. Increasing anesthetic gas consumption increases the cost of the anesthetic gas in the surgical environment.
The use of volatile anesthetics such as desflurane or sevoflurane during general anesthesia causes an increase in lipid peroxidation or proinflammatory cytokines in macrophages, leading to generalized inflammatory reactions. It is stated that all these can cause oxidative stress, and under general anesthesia, patients are exposed to oxidative stress caused by volatile anesthetics. However, laparoscopic cholecystectomy, which has become a common procedure due to its advantages, increases the intraabdominal pressure, liver, splanchnic vessels, mesenteric hypoxia, ischemia. It causes reperfusion damage and consequently an increase in oxidative stress. Sevoflurane is a widely used anesthetic agent, its anti-inflammatory and antioxidant properties have been demonstrated in various studies, it has been shown that it protects against ischemia-reperfusion damage in vital organs such as heart, lung and kidney, and has more protective effects on thiol disulfide homeostasis than desflurane.
Thiols are compounds containing sulfur group, which are essential antioxidant buffers that interact with almost all physiological oxidants. Thiol groups are oxidized by the surrounding oxidant molecules and converted to disulfide structures and then thiol groups, thiol disulfide balance was a sustainable reaction. Thiols act as fast electron acceptors and play an important role in defending against reactive oxygen species by contributing a large part of the total antioxidants present in the body. Plasma thiols have pro-oxidant or antioxidant effects on physiological events; but they are generally regarded as antioxidants. It also plays a critical role in programmed cell death, detoxification, antioxidant protection and regulation of cellular enzymatic activity. Measuring thiols in serum may show an indirect reflection of antioxidant defense. Another oxidation parameter that can be used as a perioperative ischemia marker is ischemia-modified albumin (IMA). Hypoxia, acidosis, and superoxide radical damage cause IMA formation by altering the structure of the N terminal, reducing the binding capacity of albumin to metals. IMA is an early-rising indicator of ischemia, it increases in as little as 6 minutes. Anesthesia method, surgical method, medications used, infection and operation time affect postoperative morbidity and mortality by changing the stress response.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low flow Anesthesia group | Experimental | Procedure: low and high flow AnesthesiaAntioxidant parameters are measured in the low flow anesthesia group. |
| high flow Anesthesia gruop | Active comparator | Procedure: low and high flow AnesthesiaAntioxidant parameters are measured in the high flow anesthesia group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II
- Aged 18-70 years
- elective laparoscopic cholecystectomy surgery
- general anesthesia
Key exclusion criteria (12 listed)
- Morbidly obese patients
- alcohol or drug addiction
- chronic obstructive pulmonary disease
- coronary artery disease
- congestive heart failure
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 |
|---|---|---|
| low and high flow AnesthesiaAlso: Cholecystectomy Surgerycomparison of hemodynamic changes in low and high flow anesthesia groups | Procedure or surgery | high flow Anesthesia gruop, low flow Anesthesia group |
Primary outcome
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
Time frame: 24 hours after operation
In order to determine thiol / disulphid homeostasis and IMA serum level, 5 ml blood samples were taken 3 times from each patient (T0: 5 minutes before induction of anesthesia, T1: 5 minutes after abdominal gas is completely evacuated, T2: 24 hours postoperatively). Serum disulfide/thiol homeostasis measurements were determined by the automated spectrophotometric method described by Erel and Neşelioğlu.Thiol/disuphide hemostasis parameters were studied with the same serum samples in the same session. Ischemia modified albumen Bar-Or et al. The study was carried out using the spectrophotometric method suggested by The IMA is specified as the absorption unit (AUC).
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide
Time frame: during peroperative period
During the operation, heart rate beats/min were recorded on the monitor at the 5th, 10th, 15th, 30th, 45th, 60th, 90th, 120th, 150th, 180th and 210th minutes after intubation and at the end of extubation.
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 Jun 2021.
- Individual participant dataSharing planned: No. Study protocol and results can be shared
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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.
umran karaca, 3 study director
Assistant researcher
asıye demirel, 4 principal investigator
Assistant researcher
mehmet gamlı, 5 principal investigator
Assistant researcher
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low and high flow Anesthesia in people with Laparoscopic Cholecystectomy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites 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 4 inclusion and 12 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery (time frame: 24 hours after operation). The study lists 2 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 Jun 2021.