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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator | Patients will be applyed 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium for anesthesia induction, after intubation sevoflurane will be used for anesthesia maintenance with low flow anesthesia (0.5 l/min). |
|
| General anesthesia combined with thoracic epidural anesthesia | Active Comparator | Before anesthesia induction epidural catheter will be inserted giving 7 ml bupivacaine %0.25 in saline + 50 mcg fentanyl after confirming the location of catheter, following 15 minutes the standard anesthesia induction will be applied ( 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium ). For anesthesia maintenance epidural infusion will be applied ( 7ml/h %0.25 bupivacaine solution) together with low flow (0.5 l/min) sevoflurane anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | %0.25 bupivacaine solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| End tidal volatile anesthetic concentration | End tidal volatile anesthetic concentration that keeps entropy in normal limits | up to 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Total volatile anesthetic consumption | Amount of total inhalation anesthetic consumed during surgery | up to 2 hours |
| Time to reach target concentration | Time to reach the end tidal anesthetic concentration that we set |
| Measure | Description | Time Frame |
|---|---|---|
| Total remifentanil consumption | Total remifentanil consumption when pain index (SPI) is above normal | up to end of the operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuzhet Mert Shenturk, MD, Prof | Istanbul University Faculty of Medicine Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul University | Istanbul | 34050 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Epidural lidocaine decreases sevoflurane requirement for adequate depth of anesthesia as measured by the BIS monitor | View source |
| Comparison of the effects of thoracic and lumbar epidural anesthesia on induction and maintenance doses of propofol during total i.v. anesthesia | View source |
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IPD of cases included into the study will be shared
Starting with the finalisation of the study ; for the next 5 years
Will be determined by the institutional ethical committee
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Sevoflurane | Drug | End tidal sevoflurane concentration |
|
|
| up to 10 minutes |
| Inhalation anesthetic amount the target concentration reached ( in the period of reaching the set alveolar concentration) | The amount of inhalation anesthetic consumed until reaching the target concentration | up to 5 minutes |
| The amount of propofol | The amount of using propofol for anesthesia induction | 2 minutes |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000588 |
| Amines |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |