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İMAComparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery

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What is being tested

low and high flow Anesthesia

Procedure
Who is being recruted

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorBursa Yuksek Ihtisas Training and Research Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 10, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleComparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery
NCT04926480
Principal SponsorBursa Yuksek Ihtisas Training and Research Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
ASA I-II

Aged 18-70 years

elective laparoscopic cholecystectomy surgery

general anesthesia

12 exclusion criteria prevent from participating
Morbidly obese patients

alcohol or drug addiction

chronic obstructive pulmonary disease

coronary artery disease

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Antioxidant parameters are measured in the high flow anesthesia group.

Group II

Experimental
Antioxidant parameters are measured in the low flow anesthesia group.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Bursa yüksek ihtisas training and research hospital

Bursa, Turkey (Türkiye)Open Bursa yüksek ihtisas training and research hospital in Google Maps
Suspended

Bursa yüksek ihtisas

Bursa, Turkey (Türkiye)
Completed2 Study Centers
İMA | Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery | PatLynk