Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04926480 |
| Other study ID # |
2011-KAEK-25 2019 /12-21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2020 |
| Est. completion date |
July 31, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
Bursa Yüksek Ihtisas Education and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 laparoscopic Cholecystectomy
Surgery using Sevoflurane as an anesthetic gas routinely.
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.
