Clinical trial NCT04203290: End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy
Official title: Comparison of General Anesthesia and Combined General Thoracic Epidural Anesthesia on End Tidal Volatile Anesthetic Concentration in Cases Which Depth of Anesthesia is Adjusted Using Entropy Monitoring; A Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Inhalation; Gas
Keywords: Minumum alveoler concentration
Entropy monitorining
General anesthesia
General anesthesia combined with TEA
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to adjust the end tidal inhalation anesthetic concentration by observing the entropy value in patients who will be provided anesthesia maintenance with volatile anesthetics after applying the routine epidural anesthesia technique and to observe the end tidal volatile concentration that will provide to remain in the target entropy limits during the operation.

Detailed description: The hypothesis of this study is that in general anesthesia cases which is combined with thoracic epidural anesthesia (TEA), lower alveolar concentration will be required to reach the same anesthesia depth. The main aim of the study is observing and comparing the alveolar concentrations of anesthetic agents with entropy monitoring which is an anesthesia depth monitor in major abdominal surgeries where general anesthesia is combined or not with TEA.

In cases where TEA is combined with general anesthesia or not, anesthesia depth will be effectively monitored by entropy monitoring, in this way the adequate depth of anesthesia will be provided with the use of minimal volatile anesthetics and we will be able to prevent the use of large amounts of volatile anesthetics., It will be determined how much reduction in alveolar concentration is required in cases combined with TEA.

Nowadays, with the development of reliable anesthesia machines, "low-flow anesthesia" (LFA) is becoming more widespread, and its benefits on patient health, economy and ecology have been demonstrated. In LFA, the depth of anesthesia should not be too superficial or too deep during the time the alveolar concentration of volatile agent reaches equilibrium. Therefore, alveolar concentrations of volatile anesthetics are monitored in modern anesthesia machines. Some machines may also adjust the depth of anesthesia according to the alveolar concentration of the agent.

Eligibility criteria: Inclusion Criteria:

* undergoing major abdominal surgery
* Patients who will not undergoing operation for thoracic cavity
* Body Mass Index (BMI) between 20-30

Exclusion Criteria:

* denial of patients
* contraindications for thoracic epidural anesthesia
* patients who are FEV1/FVC \< 60
* patients with thoracic and lomber vertebrae surgery

Primary outcomes:
measure: End tidal volatile anesthetic concentration
timeFrame: up to 20 minutes
Secondary outcomes:
measure: Total volatile anesthetic consumption
timeFrame: up to 2 hours
measure: Time to reach target concentration
timeFrame: up to 10 minutes
measure: Inhalation anesthetic amount the target concentration reached ( in the period of reaching the set alveolar concentration)
timeFrame: up to 5 minutes
measure: The amount of propofol
timeFrame: 2 minutes
Other outcomes:
measure: Total remifentanil consumption
timeFrame: up to end of the operation
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University
Study officials:
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Nuzhet Mert Shenturk, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: