Induction and maintenance of general anesthesia in surgical procedures in hospital and outpatient settings in adults and children.
Composition:
1 bottle (250 ml) contains 100% sevoflurane.
Action:
An inhalation worm. Sevoflurane is a halogenated methyl-isopropyl ether for inhalation of general anesthesia characterized by rapid induction of anesthesia and rapid arousal. MAC (the lowest concentration in the alveoli) depends on age. It causes loss of consciousness, reversible abolition of pain sensations and physical activity, weakening of autonomic reflexes, inhibition of respiratory function and circulatory system. These effects depend on the dose. Sevoflurane has a low blood / gas partition coefficient (0.63-0.69), which allows for quick recovery from anesthesia. The drug may cause a concentration-dependent decrease in blood pressure. It shows the action sensitizing the myocardium to the arrhythmogenic effect of exogenously administered adrenaline. Sevoflurane is sparingly soluble in blood and tissues, resulting in rapid achievement of adequate alveolar concentration to induce anesthesia and subsequent rapid elimination until complete anesthesia is discontinued. Less than 5% of absorbed sevoflurane is metabolized in the liver to hexafluoro isopropanol (HFIP), with inorganic fluorides and CO2 (or one-carbon compounds). Once formed, HFIP undergoes rapid conjugation with glucuronic acid and elimination in the urine. Fast and intensive elimination of sevoflurane by the lungs reduces to a minimum the amount of the drug available for metabolism. The metabolism of sevoflurane is not induced by barbiturates.
Contraindications:
Hypersensitivity to sevoflurane or other halogen anesthetics. Diagnosis or suspicion of genetically determined malignant hyperthermia. Patients with general anesthesia contraindicated.
Precautions:
Caution should be exercised in patients at risk of QT prolongation (eg in patients with congenital QT prolongation syndrome), with mitochondrial diseases, coronary heart disease (to avoid myocardial ischemia, it is important to maintain a constant level of haemodynamic parameters) at risk of elevated blood pressure (you should take measures to reduce intracranial pressure eg hyperventilation), renal failure (initial creatinine concentration> 1.5 mg / 100 ml, no safety established), with hepatic dysfunction or using drugs that affect liver function. It was reported that in the case of earlier use of inhaled halogen anesthetics, especially at an interval of less than 3 months, the risk of liver damage may increase. In susceptible patients, potent inhaled anesthetics, including sevoflurane, may trigger increased skeletal muscle metabolism, leading to increased oxygen demand and a set of clinical symptoms called malignant hyperthermia. Hypercapnia is the first signal of this syndrome, which may be manifested by muscle stiffness, tachycardia, increased respiratory rate, cyanosis, cardiac arrhythmias and / or fluctuations in blood pressure. Some of these non-specific signs may also appear during mild anesthesia, acute hypoxia, hypercapnia and hypovolemia. The use of inhaled anesthetics has been associated with rare cases of increased serum potassium, which resulted in postoperative cardiac arrhythmias and death in children - the highest risk of these events occurs in patients with latent and overt neuromuscular disease, especially Duchenne muscular dystrophy. The simultaneous use of succinylcholine was associated with the majority, though not all of these cases. Significant increases in serum creatine kinase and, in some cases, changes in urine indicating myoglobinuria were also observed in these patients.Despite the similarity of symptoms to the symptoms observed in malignant hyperthermia, none of the patients showed any signs or symptoms of muscle stiffness or hypermetabolic status. An early and energetic intervention is recommended to treat hyperkalemia and persistent arrhythmia, and then to test for latent neuromuscular disease. Increasing the sevoflurane concentration while maintaining anesthesia causes a dose-dependent decrease in blood pressure. Excessive reduction of blood pressure may be related to the depth of anesthesia and in such cases it may be corrected by reducing the concentration of inhaled sevoflurane. Special care should be taken in patients with hypovolaemia, hypotension or other haemodynamic disorders, e.g. caused by concomitant medications. The use of sevoflurane caused convulsive seizures in children and young adults as well as older people with or without risk factors. In children, the depth of anesthesia should be reduced. EEG testing may allow to determine the optimal dose of sevoflurane and help to avoid the development of seizure activity in patients prone to seizures. When sevoflurane is used in patients who may be at risk of experiencing seizures, it should be based on prudent clinical judgment.
Pregnancy and lactation:
The preparation can be used only in case of extreme necessity (no tests). The drug can be used for anesthesia for Caesarean section; no studies on the use of sevoflurane for the anesthesia of natural labor. Sevoflurane has a relaxant effect on the uterine muscle, which is associated with the potential risk of uterine bleeding. The use of sevoflurane for anesthesia in obstetrics requires clinical evaluation. There are no studies on maternal switching - breastfeeding should be discontinued 48 h after sevoflurane administration.
Side effects:
Very common: agitation, bradycardia, hypotension, cough, nausea, vomiting. Common: drowsiness, dizziness, headache, tachycardia, hypertension, respiratory disorders, laryngeal spasm, excessive salivation, chills, fever, abnormal blood Glucose levels, abnormal liver function tests, abnormal white blood cell count, increased fluoride levels blood, hypothermia. Uncommon: complete atrioventricular block. Not known: anaphylactic reaction, anaphylactoid reaction, hypersensitivity, convulsions, dystonia, cardiac arrest, bronchospasm, dyspnea, wheezing, hepatitis, hepatic failure, hepatic necrosis, contact dermatitis, pruritus, rash, facial edema, discomfort in chest, malignant hyperthermia. Individual cases of ventricular arrhythmias in children with Pompe disease were reported. There have been very rare cases of mild, moderate and severe postoperative liver dysfunction or hepatitis with jaundice or without jaundice.
Dosage:
It can only be used by people who are trained in general anesthesia, with access to oxygen and equipment to maintain airway patency and resuscitation. Inhalation, including evaporators calibrated specifically for sevoflurane. The dose should be selected individually depending on the age and condition of the patient. A short-acting barbituric acid derivative or other intravenous inducer may be given prior to the use of sevoflurane followed by breathing sevoflurane with oxygen or with a mixture of oxygen and nitrous oxide. In adults and children, the inhaled concentration of sevoflurane not exceeding 8% generally results in anesthesia for surgery in less than 2 minutes. The maintenance phase of anesthesia usually uses 0.5-3.0% considering MAC and the addition of other anesthetics or analgesics. MAC in 100% oxygen is (approximate values): for newborns - 3.3%, babies 1- <6 months - 3.0%, children 6 months - <3 years - 2.8%, children 3- 12 years - 2.5%, patients aged 25 - 2.6%, 40 years - 2.1%, 60 years - 1.7%, 80 years - 1.4% (for 80 years). When using a mixture of N2O (65%) / O2(35%) MAC is for: children 6 months- <3 years - 2%, patients aged 25 - 1.4%, 40 years - 1.1%, 60 years - 0.9%, 80 years - 0.7%.